The effect of an mHealth application based on continuous support and education on fear of childbirth, self-efficacy, and birth mode in primiparous women: A randomized controlled trial

Sahar Khademioore; Elham Ebrahimi; Ahmad Khosravi; Shohreh Movahedi

doi:10.1371/journal.pone.0293815

. 2023 Nov 1;18(11):e0293815. doi: 10.1371/journal.pone.0293815

The effect of an mHealth application based on continuous support and education on fear of childbirth, self-efficacy, and birth mode in primiparous women: A randomized controlled trial

Sahar Khademioore ^1,^¤,^*, Elham Ebrahimi ¹, Ahmad Khosravi ², Shohreh Movahedi ³

Editor: Hector Lamadrid-Figueroa⁴

PMCID: PMC10619799 PMID: 37910495

Abstract

Background

The Fear of Childbirth (FOC) is associated with several adverse health outcomes for children and women. This study aimed to evaluate the effectiveness of an interactive mobile health application named Tele-midwifery with an emphasis on continuous care and education, on FOC, self-efficacy, and childbirth mode in primiparous women.

Methods

Seventy primiparous women attending the prenatal clinic of Baharlou Hospital in Tehran, Iran, were randomly assigned to two parallel intervention and control groups with 35 participants each. Women in the intervention group received Tele-midwifery for eight weeks, whereas women in the control group only received routine care. The Wijma delivery expectancy/experience questionnaire and the Childbirth Self-Efficacy Inventory were used to measure the FOC and self-efficacy at baseline and eight weeks after the intervention. The FOC and birth mode were also measured after birth.

Results

There was a significant decrease in FOC among women in the intervention group compared to control groups after eight weeks of intervention (- 20.9 [95% Confidence Interval,—24.01 to—17.83], p < 0.001), and after birth (- 30.8, [95% CI—33.8 to—27.97], p < 0.001). After eight weeks, the mean self-efficacy score in the intervention group was significantly higher than the control group (p < 0.001). Compared to the control group, the intervention group had a lower C-Section (CS) rate (p = 0.03).

Conclusions

Tele-midwifery intervention reduced FOC, increased women’s self-efficacy in childbirth, and decreased the number of CS in a group of first-time mothers. Healthcare providers can use the mHealth approach to support pregnant women with FOC.

Trial registration

Registration number: IRCT20200122046227N1, Registered on 27 January 2020.

Introduction

Fear of childbirth (FOC) is a well-known problem affecting women, especially primiparous during pregnancy and postpartum period [1]. FOC is defined as severe anxiety related to childbirth, which can manifest through sleep disorders, physical complaints, and lack of focus on work or social life [2]. According to a large-scale systematic review and meta-analysis of 29 studies on 853,988 pregnancies, the global prevalence of FOC was reported to be 14 percent (95% Confidence Interval (CI) 0.12–0.16), with an increasing trend in recent years [3]. Women suffering from FOC are at increased risk of maternal and child health complications such as prolonged labor, increased use of analgesia, higher rate of emergency and elective and C-Section (CS), post-traumatic stress disorder, and postpartum depression [4–6]. Previous studies showed that FOC is also strongly associated with a lack of childbirth self-efficacy, especially in first-time mothers [7]. Self-efficacy plays a vital role in adopting to pregnancy and childbirth, and can affect women’s attitude and motivation for a vaginal birth rather than requesting CS [8]; As a result, the adverse effects of CS on mothers and their children will be prevented, and the unnecessary costs for the healthcare system due to the high rate of CS will be reduced [9].

Even though various interventions such as yoga, art therapy, and counseling, have been shown to be effective in reducing FOC, there is no consensus regarding the best treatment for alleviating women’s fears [10]. Furthermore, some of these interventions are time-consuming, expensive, dissatisfying to pregnant women, and difficult to implement [11]. Due to these challenges, technology-based methods, such as Mobile health applications (mHealth), have gained attention in various fields to improve women’s health (e.g., mental health) [12]. A key advantage of mHealth is the accessibility of healthcare services, such as educational content or consultations, regardless of time or space constraints [13]. Pregnant women report greater satisfaction in receiving pregnancy-related services through mobile applications [14, 15], which offer continuous care and lead to a positive pregnancy and childbirth experience [16]. mHealth is an efficient and popular technology that has women’s acceptance and can improve one’s ability to face various challenging situations [17]. Providing education and continuous support for pregnant women can eliminate many causes of FOC and improve their self-efficacy, contributing to better preparedness for pregnancy and childbirth [18, 19]. Receiving education via mHealth applications and providing continuous care can lead to greater sense of responsibility for obtaining information and learning, which results in in-depth knowledge and awareness [20].

Preventing FOC and promoting positive attitudes towards childbirth during pregnancy are critical factors in reducing the risk of traumatic childbirth and other complications associated with pregnancy and childbirth. Currently, there is no systematic approach for screening and treating women with FOC [21]. Considering the lack of specialized services for women with FOC, integrating effective interventions such as an mHealth application based on education and continuous support with the healthcare system can be an effective approach for providing tailored care to pregnant women. The application of mHealth based on the education and continuous support on improving the FOC, has received little attention, especially among Iranian pregnant women. Thus, in this study, an mHealth application was considered a possible strategy for treating women with FOC, improving their self-efficacy, and reducing the CS rate.

Materials and methods

Study design and eligibility criteria

We conducted a Randomized Clinical Trial (RCT) to evaluate the effectiveness of using an mHealth application called Tele-midwifery to reduce FOC, increase childbirth self-efficacy, and reduce the number of CS among primiparous women. The research setting was the perinatal clinic of Baharlou Hospital in Tehran, Iran, and enrollment took place from February to April 2020.

Inclusion criteria in this study were: being primiparous, having FOC (confirmed by the score of 38 and above on the Wijma delivery expectancy/experience questionnaire (W-DEQ)), being between 18 to 40 years of age, pregnant with a singleton fetus, 26–29 weeks of pregnancy, having access to a smart device such as a smartphone, or a tablet (women or their spouses), as well as the ability to work with them, having access to the Internet, not having chronic diseases and CS indications before or during pregnancy. The exclusion criteria were, emergency pregnancy conditions that required intervention (e.g., severe symptoms of COVID-19, placental abruption, fetus abnormalities, preeclampsia).

Outcomes

The primary outcome of this study was a change in FOC score. The secondary outcomes were a change in childbirth self-efficacy score, and childbirth mode.

Measures

In this study, the fear related to childbirth in the prenatal and postnatal period was measured using W-DEQ versions A and B. W-DEQ version A evaluates women’s prenatal expectances before childbirth, and W-DEQ version B evaluates experiences with recent childbirth. Each version contains 33 items with a 6-point Likert scale ranging from 0 (extremely) to 5 (not at all), and scores range from 0 to 165, with higher scores indicating higher fear of childbirth [22]. According to this questionnaire, a score less than or equal to 37 represent mild fear, a score of 38–65 represents a moderate level, 66–84 represents high level of fear, and a score more than 85 shows a severe level of fear. The reliability of the W-DEQ version A and B questionnaire for primiparous women was confirmed with Cronbach’s alpha of 0.89 and 0.92, respectively [22]. The validity and reliability of the Persian version of this questionnaire for Iranian women have been confirmed [23].

The Childbirth Self-Efficacy Inventory (CBSEI) is a self-report instrument that measures outcome expectancies (OE) and efficacy expectancies (EE) for coping with an approaching childbirth experience. This questionnaire has two parts and 62 items that scored on a ten-point Likert scale (1 = not at all; 10 = completely sure), with a higher score indicating greater childbirth self-efficacy. The reliability of the questionnaire has been confirmed with Cronbach’s alpha 0.86–0.95 [24]. The validity and reliability of the Persian version of this questionnaire were assessed by Khorsandi et al. (2008). In their study, high internal consistency with Cronbach’s alpha coefficient of 0.84 to 0.91 was reported for the CBSEI [25].

Sample size

The sample size was calculated based on our primary outcome which was FOC. We referred to the results of Gözde Birsbir et al.’s (2016) study on the effect of antenatal education on FOC to estimate our sample size [26]. A two-sided t-test of difference between means with a power of 90%, the type one error equal to 0.05, a mean difference of 21 scores between groups on the W-DEQ scale for FOC was considered to estimate the required number of participants. In the sample size calculation, we also accounted for a 20% attrition rate. A sample size of 70 pregnant women (35 in each group) was estimated.

Procedures

A convenience sampling approach was used, and a consecutive sample of pregnant women attending to the selected prenatal clinic for receiving their routine prenatal care were evaluated using their medical records for inclusion and exclusion criteria, by a colleague not involved in the study. Afterward, the objectives of the study were explained to eligible pregnant women. After consent was obtained, they were asked to complete the W-DEQ version A. women with a score of 38 and above (moderate and high FOC score) were enrolled in the study. A total of 214 pregnant women were evaluated for recruitment in the study. Specifically, 98 women did not meet the inclusion criteria, and 32 women declined to participate. Overall, 70 eligible individuals were randomly assigned to intervention (Tele-midwifery application) and control groups, with 35 participants in each (Fig 1).

A randomized allocation into two groups of intervention and control with a 1: 1 ratio took place during the routine prenatal visit in the hospital. A colleague who was not involved in the study put each computerized generated random sequences separately in sealed and opaque envelopes. To mask the person performing the allocation, the letters A and B were used to assign women to the intervention or control group. In both intervention and control groups, the Tele-midwifery application was installed on their smartphones during their prenatal visit, and instructions for using the application were explained. This application only allowed access to the questionnaires in the post-test, and follow-up stages for participants in the control group. However, the intervention group had access to all features of the application. The researcher could track the women’s activities in the application, and in case the women had not use the application for more than two days, a reminder was sent to follow them up. To prevent information contamination in the control group, after installing the application and before activating their account, women selected their group type as A or B. In addition, we asked the women in both groups to avoid sharing the contents of the application with each other for the duration of the trial. The Tele-midwifery application had two main stages for answering the questions. After filling out the baseline questionnaire in the initial registration, including demographic, W-DEQ, and CBSE questionnaires, each groups of participants completed the W-DEQ and CBSE questionnaires again at 34–36 weeks (after eight weeks of receiving the intervention). Participants were also asked to inform the researcher by sending a message after hospitalization for their birth, whether in the Tele-midwifery application or by contacting the researcher directly by her phone number. Afterward, the W-DEQ version B questionnaire appeared in the application within the first two hours after birth, and the birth mode was recorded. Due to the nature of the intervention, it was not possible to mask participants from the group allocation. However, investigators, care providers, data collectors, and statisticians were masked from the allocation.

Tele-midwifery application

First, to prepare the Tele-midwifery application’s content, reliable and up-to-date scientific sources such as textbooks, scientific articles, related guidelines, studied carefully by the research team, and necessary content in various fields were reviewed [10, 27–30]. This content included videos, audios and short texts with related images produced by the research team to make it understandable for all women with any level of education and increase attractiveness. In the next stage, the content’s validity was evaluated by three relevant experts (reproductive health, gynecologist, and mental health specialist), then sent to software experts in a format that can be used as a mobile application. Finally, the application was used as a trial version by five pregnant women who were not involved in the study, in which aspects such as comprehensibility, simplicity of its contents, and user-friendliness were checked. Then the comments of these users were applied to modify the application, and the final version was prepared.

Dimensions of intervention

Education

The educational content of the Tele-midwifery application was designed to include all possible causes of FOC in Iranian women, such as fear of labor pain, lack of information related to the mother and baby’s health, what women should expect during labor and birth, the characteristics of each stage of labor, misconceptions such as distrust of healthcare providers, and complications of vaginal birth [31, 32]. The list of educational content is shown in Table 1. The educational content included information and exercises to increase women’s knowledge and challenge their underlying beliefs causing the FOC. Besides the educational information in the form of text, audio, video, and image, this dynamic application provides the opportunity for women receiving the intervention to ask their question regarding the educational content within a chat box available in the application. Educational content was also accessible offline for women on an archive in the application. The application’s educational content was designed for eight weeks in a way that between 3–4 short messages were sent to women on a daily basis. After eight weeks, women in both the intervention and control groups received the next stage (post-test) questionnaires.

Table 1. Five components of educational content of Tele-midwifery application.

Content	Details	Teaching methods and number
1. Pregnancy	The third trimester complications, healthy eating, relaxation technique, emotional change in pregnancy, fetal development, female anatomy, sharing feelings and concerns related to pregnancy, COVID-19 symptoms, and preventive measures	Videos: 2 Texts: 23 Pictures: 10 Audio: 2
2. Labor and childbirth	Signs of labor, different stages of labor, coping techniques with labor, including, breathing and relaxation exercises, birth positions, massage, hydrotherapy, aromatherapy, pushing techniques, birth support partner, common myth about labor contractions, share feelings and thoughts about labor and childbirth, identify feeling about childbirth, visualization of childbirth	Video: 1 positive childbirth experience stories video and audio: 3 pictures:5 Texts: 10
3. Interventions during the labor and childbirth	Induction and augmentation of labor, episiotomy, epidural, amniotomy, vaginal examinations in labor, preparing a birth plan, visualization of childbirth according to the birth plan	Videos: 1 Texts: 10 Pictures: 5 Audio: 3
4. Childbirth mode	Cesarean section: indications, side effects, surgery preparation, recovery, operative vaginal birth: forceps or a vacuum extractor	Videos: 1 Texts: 5 Pictures: 2 Audio:1
5. Postpartum	Physical and psychological changes during the postpartum period, parenthood, mother-baby interaction, breastfeeding, newborn care, nutritional care, postpartum sexuality, family planning, sharing feeling and thought about the postpartum period	Videos: 1 Texts: 15 Pictures: 8 Audio: 4

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Continuous support and engagement of women

To provide continuity of care and support between two prenatal visits, participants in the intervention group, could contact the researchers if they had concerns and questions about their pregnancy and birth care. The team of researchers including midwives and obstetricians were available throughout the day (between 7 a.m. to 9 p.m.), to provide women with an accessible source of information about their pregnancy and childbirth decisions. However, this feature was not intended to substitute the usual antenatal care, and no medication prescriptions, requesting laboratory tests, or imaging were offered via our mHealth. They could also write about their feelings and experiences publicly in the forum linked to the educational contents, and pregnant women had the opportunity to exchange their feelings with each other under the research team’s supervision. The mHealth application can also help women in expressing their feelings and symptoms due to the anonymity of this method of delivering the intervention [33].

The control group received only routine prenatal care. Currently there are no specific guidelines in Iran, for providing care to pregnant women suffering from FOC. The routine prenatal care in Iran includes up to 8 prenatal visits, which in the study site would be provided to all pregnant individuals by midwives and obstetricians. Routine prenatal care includes regular visits to monitor women and fetal health. To better access women in the control group and limit in-person interaction due to the COVID-19 pandemic, we asked them not to uninstall the application from their mobile phones until birth and answer questionnaires after eight weeks and after childbirth.

Statistical analyzes

The data analyzed by IBM SPSS statistics version 25 and p-value > 0.05 was considered as a statistically significant level. To compare statistical differences of demographic data in intervention and control groups, an independent t-test, Chi-square test, and Fisher’s exact test were used. The repeated-measures analysis of variance (ANOVA) was used to compare the mean score of FOC between intervention and control groups at different time points (baseline, after 8 weeks, after childbirth). Linear regression models used to estimate the change in FOC and self-efficacy score in the intervention group compared to the control group in different time points. Also, for analyzing the birth mode, Chi-square were used to determine the differences between the groups. A Logistic regression model was also performed to estimate the odds of CS in the intervention group compared to the control group.

Ethical considerations

The ethics committee of Tehran University of Medical Sciences approved the research procedure (IR.TUMS.FNM.REC.1398.135). At the beginning of the study, the researchers provided the necessary explanations about the intervention and the study’s objectives to the participant. After receiving sufficient information from various aspects of the research, all participants provided a signed written informed consent, and they could leave at any stage of the research. Each woman was assigned a unique code to ensure the confidentiality of their medical information, which prevented the identification of the participants.

Results

A total of 70 nulliparous women with FOC enrolled in the study in two intervention (n = 35) and control (n = 35) groups. There was no loss to follow-up, and no exclusion from the study based on our criteria, and although we prepared to refer participants in case of an emergency, no such contacts were made during the study period and all 70 participants were included in the final analysis. In this study, the mean age of participants in the intervention group was 24.3 years, and 25.6 years in the control group. The majority of women’s gestational age in the intervention and control groups at the beginning of the study was 28 weeks (40% in the intervention group and 45.7% in the control group). According to Table 2, there was no statistically significant difference between the groups regarding sociodemographic characteristics (p > 0.05).

Table 2. Characteristics of the participants.

(n = 70).

Characteristics	Intervention (n = 35)	Control (n = 35)	P-value
Women’s age (Mean ±SD, years)	24.3 ± 3.5	25.6 ± 3.5	0.1^***
Spouse age (Mean ±SD, years)	28.8 ± 3.4	29.5 ± 3.1	0.3^***
Gestational age (Mean ±SD, weeks)	27.7 ± 0.8	27.4 ± 0.7	0.1^***
Women’s education status n (%)
Primary/secondary school	4 (11.4)	4 (11.4)	0.7^*
High school/diploma	23 (65.7)	20 (57.1)
University	8 (22.9)	11 (31.5)
Spouse education status n (%)
Primary/secondary school	8 (22.8)	6 (17.1)	0.3^*
High school/diploma	19 (54.3)	22 (62.9)
University	8 (22.9)	7 (20.0)
Family income n (%)
Less than expenses	12 (34.3)	9 (25.7)	0.5^*
Equal to expenses	20 (57.1)	20 (57.2)
More than expenses	3 (8.6)	6 (17.1)
Women occupation n (%)
Housewife	19 (54.3)	22 (62.9)	0.4^**
Employee	16 (45.7)	13 (37.1)	0.4^**
Spouse occupation n (%)
Laborer	6 (17.1)	2 (5.7)	0.3^*
Governmental	11 (31.4)	11 (31.4)
Nongovernmental	18 (51.5)	22 (62.9)
Pregnancy intention n (%)
Intended	24 (68.6)	19 (54.3)	0.2^**
Unintended	11 (31.4)	16 (45.7)	0.2^**

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*Fisher Exact Test

**Chi square test

***Independent t-test

FOC

A repeated-measures ANOVA with a Greenhouse-Geisser correction for within-subject effects of FOC scores showed that time and the group interaction effect is significant for this variable (time*group: F = 131, p < 0.001). To compare groups at different time-points (baseline, after 8 weeks, and after childbirth), linear regression model was used. There was no statistically significant difference in mean scores of FOC in the intervention and control groups at the baseline (p = 0.10). The result of linear regression model showed that on average the estimated score of FOC for individual in the intervention group is 21.14 scores lower than those in the control group (95% CI [-23.94, -18.34]; p <0.0001, R² = 0 .77) after 8 weeks of intervention. Furthermore, the FOC score after childbirth was improved by an estimated of 31.23 score more on average in the intervention group compared to those in the control group (95% CI [-33.82, -28.64], p <0.0001, R² = 0 .90) (Table 3). The findings remained consistent after adjusting for age, income, education, and baseline fear (S1 Table in S3 File). In summary, the result shows that on average the intervention group had statistically significantly lower FOC scores compared to the control group after 8 weeks and after birth (Fig 2, S2 Table in S3 File).

Table 3. Effect of mHealth application on FOC score in intervention group compared to control group at different time points (n = 70).

Time/ Group	Coefficient	SE	95% CI		P-Value
Time/ Group	Coefficient	SE	LL	UL	P-Value
Baseline
Intervention vs. Control	2.83	1.70	-0.56	6.21	0.10
After 8 weeks
Intervention vs. Control	- 21.14	1.40	-23.94	-18.34	<0.0001
After childbirth
Intervention vs. Control	-31.23	1.30	-33.82	-28.64	<0.0001

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SE = Standard Error, CI = Confidence Interval, LL = lower Limit, UL = Upper Limit

Childbirth self-efficacy

There was no statistically significant difference in mean scores of childbirth self-efficacy between the intervention and control groups at the baseline (p = 0.07). According to the result of linear regression it is estimated that on average those in the intervention group have an 85.60scores more than those in the control group after 8 weeks of intervention (95% CI [80.56, 90.64], P value <0.0001, R² = 0.94) (Table 4). The results remained constant after adjusting for age, income, education, and baseline childbirth self-efficacy score (S3 Table in S3 File). The comparison of the mean score of childbirth self-efficacy and its subscales in the intervention and control groups are reported in S4 Table in S3 File.

Table 4. Effect of mHealth application on self-efficacy score in intervention group compared to control group at baseline and 8 weeks after intervention (n = 70).

Time/Group	Coefficient	SE	95% CI		P-Value
Time/Group	Coefficient	SE	LL	LL	P-Value
Baseline
Intervention vs. Control	3.60	1.98	-0.35	7.55	0.07
After 8 weeks
Intervention vs. Control	85.60	2.55	80.56	90.64	<0.0001

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SE = Standard Error, CI = Confidence Interval, LL = lower Limit, UL = Upper Limit

Birth mode

Two intervention and control groups had a statistically significant difference in their birth mode (p = 0.03). The intervention group had a lower rate of CS than the control group (31.4% in the intervention group versus 60% in the control group). The result of the logistic regression showed that the odds of CS are approximately 3.27 times higher in the control group compared to the intervention group (95% CI 1.22, 8.75). The adjusted model for age, family income, education showed similar results.

Discussion

This study aimed to determine the effect of an interactive mHealth application named Tele-midwifery based on education and continuous support provided by midwives on FOC, childbirth self-efficacy, and birth mode in primiparous women. Based on the results of this study, Tele-midwifery application reduced FOC, increased childbirth self-efficacy, and decreased the CS rate among the intervention group compared to the control group.

Women in the intervention group received educational materials, including a broad range of information regarding pregnancy and childbirth, in order to enhance their knowledge and eliminate their misconceptions about childbirth, which contribute to FOC [34]. Education will assist women in addressing their concerns regarding childbirth, as well as providing them with confidence that their children and themselves will not be in danger. This will help them in coping with their fears related to childbirth [35]. Our findings are in line with previous studies which used educational content as their intervention for reducing FOC, increasing self-efficacy, and decreasing the number of CS [26, 36, 37]. The results of the Shahsavan et al. (2021) study also showed that an educational program based on cognitive-behavioral therapy significantly reduced the FOC in pregnant women [38]. However, the reduction in FOC score in Shahsavan et al. study was less than in our study, which can be due to the lower baseline FOC score and the difference in the educational training in Shahsavan et al. study compared to ours. The prominent role of continuous support and online services in our study compared to the Shahsavan et al. study can be another reason for this discrepancy. Toohl et al. (2014) used a telephone-based psycho-education intervention offered by midwives to reduce FOC and increase self-efficacy [37]. The intervention used in their study is similar to the present study in terms of providing virtual education and counseling by midwives. However, the mean score of increased childbirth self-efficacy in Toohl et al. was less than in our study. This difference can be due to the shorter intervention duration (only two telephone sessions in Toohl et al. study) and lack of continuous support compared to the present study. FOC is negatively associated with childbirth self-efficacy and CS in pregnant women. The reduction in FOC may have had a significant effect on improving women’s self-efficacy and reducing the number of CS in the intervention group compared to the control group. Fearful pregnant women consider childbirth as a complicated and challenging process and beyond their abilities, which contributes to a reduced childbirth self-efficacy, and higher number of CS [39]. According to Taheri Z et al. (2014) [40] and Stoll k et al. (2015) [41] the lower FOC and increased self-efficacy were associated with a lower CS rate among pregnant women. These results were consistent with the present study, as the CS rate in women in the intervention group was 28.6% higher than the control group.

Our intervention’s emphasis on continuity of care may be another explanation for the reduced FOC in the intervention group compared with the control group at the end of pregnancy and after childbirth [42]. Consistent with the present study, Hildingsson et al. (2018) used the caseload midwifery method and continuous support during pregnancy and childbirth, as well as counseling women to eliminate the causes of FOC, which reduced the fear in women [43].

The method used in this study was a mHealth-based intervention that provided remote access to evidence-based healthcare, such as education and consultation for women with FOC. Using the mobile health applications to provide healthcare is an effective means of ensuring that professional healthcare is available, affordable, and accessible to all individuals, particularly pregnant women [44]. The intervention used in this study addressed the problem of limited access to health care, particularly during the COVID-19 pandemic, when in-person prenatal care decreased, without an alternative that could provide remote care [45]. Furthermore, mHealth care reduces commuting and absence time from work for pregnant women [44], in rural areas in particular, where the shortage of health care providers and limited transportation lead to adverse outcomes for both women and children [46]. Multiple studies have shown that mHealth methods are proper for prenatal care, such as education and consultation [47, 48]. Our findings are also consistent with these results. Thus, the method used in this study can be considered a beneficial approach for offering care to pregnant women with FOC.

Strengths and limitations of research

This study was conducted during the COVID-19 pandemic; thus, it can be complicated to generalize the study’s results to normal conditions. Lack of access to childbirth preparation classes and the high risk of getting infected by in-person visits caused pregnant women to raise more concerns about their health. Therefore, one of the possible explanations for adherence to intervention, may be the accessibility of Tele-midwifery intervention during the COVID-19 crisis, which answered their needs and provided continuous care.

In this study we did not capture the frequency and nature of interactions between participants and healthcare providers who delivered the continues support feature of mHealth intervention through the application. Consequently, the specific types of support, the average frequency of provider contact (such as interactions per day or week), and the potential impact of these interactions on maternal health outcomes remain unexplored in this study. Future research is needed to delve deeper into understanding the dynamics and potential benefits of such interactions for expecting mothers.

According to the latest statistics available to the public, in Baharlou Hospital, there are approximately 350 births each month, comprising 38% CS [49]. While compared to the pre-pandemic period, the rate of CS increased during the COVID-19 pandemic [50], the high rate of CS in Iran has always been a challenge in the field of maternal health [51]. Although this study suggests a possible approach to reduce the number of CS, the rate of CS in this study, and overall in Iran [52] is still higher than the world health organization (WHO) recommendation (maximum of 15%) [53], and further research is needed to identify contributing factors to this high number of CS.

Implications for future research

In this study, participants received continuous support for addressing their questions throughout the week. However, replicating such personalized attention on a larger scale could be challenging. Real-world implementation might lack sufficient qualified healthcare professionals in the field of obstetrics, potentially affecting intervention quality and adherence. Additionally, strategies to bridge the gap between controlled settings and real-world scenarios during scaling up need to be explored to maintain intervention quality. Future studies are also needed to investigate the effects of this study’s intervention by considering additional variables such as the number of antenatal care visits and child outcomes, including stillbirth and preterm birth. Recruiting multiparous and primiparous into future research can also be another area before implementing this study intervention in real settings.

Conclusion

In this randomized clinical trial, women who received the Tele-midwifery intervention reported less FOC and more childbirth self-efficacy after receiving the Tele-midwifery application. Furthermore, the rate of CS decreased in the intervention group. Based on the results, the mHealth application can be considered a supportive treatment for women diagnosed with FOC childbirth, especially during crises such as the COVID-19 pandemic, which limits access to health settings due to preventive measures.

Supporting information

S1 File. Protocol of the study.

(DOCX)

Click here for additional data file.^{(38.3KB, docx)}

S2 File. CONSORT checklist.

(DOC)

Click here for additional data file.^{(220KB, doc)}

S3 File. S1-S4 Tables.

(DOCX)

Click here for additional data file.^{(18.7KB, docx)}

Acknowledgments

We wish to thank all the participants for generously contributing their time and experience to this study. We are grateful for the support received from all the members of the Obstetrics and Gynecology Department and Bahar clinic in Baharlou hospital.

Data Availability

The authors confirm all the data collected in this study has been thoroughly presented within the paper. However, this study was conducted in a single center over a short period of time, so making the data set public may lead to participant identification. Data set will be available upon request from the ethics committee of Tehran University of Medical Sciences at Ethics@sina.tums.ac.ir.

Funding Statement

The authors received no specific funding for this work.

References

1.Shakarami A, Mirghafourvand M, Abdolalipour S, Jafarabadi MA, Iravani M. Comparison of fear, anxiety and self-efficacy of childbirth among primiparous and multiparous women. BMC Pregnancy and Childbirth. 2021;21(1):642. doi: 10.1186/s12884-021-04114-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
2.Wijma K, Wijma B, editors. A Woman Afraid to Deliver: How to Manage Childbirth Anxiety2017.
3.O’Connell MA, Leahy‐Warren P, Khashan AS, Kenny LC, O’Neill SM. Worldwide prevalence of tocophobia in pregnant women: systematic review and meta‐analysis. Acta obstetricia et gynecologica Scandinavica. 2017;96(8):907–20. doi: 10.1111/aogs.13138 [DOI] [PubMed] [Google Scholar]
4.Dencker A, Nilsson C, Begley C, Jangsten E, Mollberg M, Patel H, et al. Causes and outcomes in studies of fear of childbirth: A systematic review. Women and birth: journal of the Australian College of Midwives. 2019;32(2):99–111. doi: 10.1016/j.wombi.2018.07.004 [DOI] [PubMed] [Google Scholar]
5.Laursen M, Johansen C, Hedegaard M. Fear of childbirth and risk for birth complications in nulliparous women in the Danish National Birth Cohort. BJOG: An International Journal of Obstetrics & Gynaecology. 2009;116(10):1350–5. doi: 10.1111/j.1471-0528.2009.02250.x [DOI] [PubMed] [Google Scholar]
6.Serçekuş P, Okumuş H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009;25(2):155–62. doi: 10.1016/j.midw.2007.02.005 [DOI] [PubMed] [Google Scholar]
7.Salomonsson B, Gullberg MT, Alehagen S, Wijma K. Self-efficacy beliefs and fear of childbirth in nulliparous women. Journal of Psychosomatic Obstetrics & Gynecology. 2013;34(3):116–21. doi: 10.3109/0167482X.2013.824418 [DOI] [PubMed] [Google Scholar]
8.Ip W-Y, Tang CS, Goggins WB. An educational intervention to improve women’s ability to cope with childbirth. Journal of Clinical Nursing. 2009;18(15):2125–35. doi: 10.1111/j.1365-2702.2008.02720.x [DOI] [PubMed] [Google Scholar]
9.Sandall J, Tribe RM, Avery L, Mola G, Visser GH, Homer CS, et al. Short-term and long-term effects of caesarean section on the health of women and children. Lancet. 2018;392(10155):1349–57. doi: 10.1016/S0140-6736(18)31930-5 [DOI] [PubMed] [Google Scholar]
10.O’Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O’Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021;7(7):Cd013321. doi: 10.1002/14651858.CD013321.pub2 [DOI] [PMC free article] [PubMed] [Google Scholar]
11.Striebich S, Mattern E, Ayerle GM. Support for pregnant women identified with fear of childbirth (FOC)/tokophobia—A systematic review of approaches and interventions. Midwifery. 2018;61:97–115. doi: 10.1016/j.midw.2018.02.013 [DOI] [PubMed] [Google Scholar]
12.Bayrampour H, Trieu J, Tharmaratnam T. Effectiveness of eHealth Interventions to Reduce Perinatal Anxiety: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019;80(1). doi: 10.4088/JCP.18r12386 [DOI] [PubMed] [Google Scholar]
13.Mupinga DM. Distance education in high schools: Benefits, challenges, and suggestions. The clearing house: a journal of educational strategies, Issues and Ideas. 2005;78(3):105–9. [Google Scholar]
14.O’Brien E, Rauf Z, Alfirevic Z, Lavender T. Women’s experiences of outpatient induction of labour with remote continuous monitoring. Midwifery. 2013;29(4):325–31. doi: 10.1016/j.midw.2012.01.014 [DOI] [PubMed] [Google Scholar]
15.Rauf Z, O’Brien E, Stampalija T, Ilioniu FP, Lavender T, Alfirevic Z. Home labour induction with retrievable prostaglandin pessary and continuous telemetric trans-abdominal fetal ECG monitoring. PLoS One. 2011;6(11):e28129. doi: 10.1371/journal.pone.0028129 [DOI] [PMC free article] [PubMed] [Google Scholar]
16.Sandall J, Soltani H, Gates S, Shennan A, Devane D. Midwife-led continuity models versus other models of care for childbearing women. Cochrane Database Syst Rev. 2016;4:Cd004667. doi: 10.1002/14651858.CD004667.pub5 [DOI] [PMC free article] [PubMed] [Google Scholar]
17.Hanach N, de Vries N, Radwan H, Bissani N. The effectiveness of telemedicine interventions, delivered exclusively during the postnatal period, on postpartum depression in mothers without history or existing mental disorders: A systematic review and meta-analysis. Midwifery. 2021;94:102906. doi: 10.1016/j.midw.2020.102906 [DOI] [PubMed] [Google Scholar]
18.Wigert H, Nilsson C, Dencker A, Begley C, Jangsten E, Sparud-Lundin C, et al. Women’s experiences of fear of childbirth: a metasynthesis of qualitative studies. International Journal of Qualitative Studies on Health and Well-being. 2020;15(1):1704484. doi: 10.1080/17482631.2019.1704484 [DOI] [PMC free article] [PubMed] [Google Scholar]
19.Zengin H, Bafali IO, Caka SY, Tiryaki O, Cinar N. Childbirth and Postpartum Period Fear and the Related Factors in Pregnancy. Journal of the College of Physicians and Surgeons—Pakistan: JCPSP. 2020;30(2):144–8. doi: 10.29271/jcpsp.2020.02.144 [DOI] [PubMed] [Google Scholar]
20.Schnitman G, Wang T, Kundu S, Turkdogan S, Gotlieb R, How J, et al. The role of digital patient education in maternal health: A systematic review. Patient Education and Counseling. 2021. doi: 10.1016/j.pec.2021.06.019 [DOI] [PubMed] [Google Scholar]
21.Richens Y, Hindley DC, Lavender T. A national online survey of UK maternity unit service provision for women with fear of birth. British Journal of Midwifery. 2015;23(8):574–9. [Google Scholar]
22.Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998;19(2):84–97. doi: 10.3109/01674829809048501 [DOI] [PubMed] [Google Scholar]
23.Mortazavi F. Validity and reliability of the Farsi version of Wijma delivery expectancy questionnaire: an exploratory and confirmatory factor analysis. Electron Physician. 2017;9(6):4606–15. doi: 10.19082/4606 [DOI] [PMC free article] [PubMed] [Google Scholar]
24.Lowe NK. Self-efficacy for labor and childbirth fears in nulliparous pregnant women. Journal of Psychosomatic Obstetrics & Gynecology. 2000;21(4):219–24. doi: 10.3109/01674820009085591 [DOI] [PubMed] [Google Scholar]
25.Khorsandi M, Ghofranipour F, Faghihzadeh S, Hidarnia A, Bagheban AA, Aguilar-Vafaie ME. Iranian version of childbirth self-efficacy inventory. Journal of clinical nursing. 2008;17(21):2846–55. doi: 10.1111/j.1365-2702.2008.02385.x [DOI] [PubMed] [Google Scholar]
26.Gökçe İsbir G, İnci F, Önal H, Yıldız PD. The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study. Applied Nursing Research. 2016;32:227–32. doi: 10.1016/j.apnr.2016.07.013 [DOI] [PubMed] [Google Scholar]
27.Marshall JE, Raynor MD. Myles’ Textbook for Midwives E-Book: Myles’ Textbook for Midwives E-Book. London, UNITED KINGDOM: Elsevier Health Sciences; 2014. [Google Scholar]
28.Torkestani F, Dokht-Abdini M, Radpouyan L, Rahimi Ghosbe S, Hadi Pour Jahromi L, Bakhshande M, et al. National guide to maternal and neonatal services: Ministry of Health, Treatment and Medical Education; 2009. [Google Scholar]
29.Cunningham FG, Leveno KJ, Bloom SL, Spong CY, Dashe JS, Hoffman BL, et al. Williams obstetrics: McGraw-Hill Medical; New York; 2014. [Google Scholar]
30.Charles J Lockwood M, MHCMUrania Magriples, MD. Prenatal care: Patient education, health promotion, and safety of commonly used drugs [https://www.uptodate.com/contents/prenatal-care-patient-education-health-promotion-and-safety-of-commonly-used-drugs.
31.Kananikandeh S, Amin Shokravi F, Mirghafourvand M, Jahanfar S. Factors of the childbirth fear among nulliparous women in Iran. BMC Pregnancy and Childbirth. 2022;22(1):547. doi: 10.1186/s12884-022-04870-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
32.Andaroon N KM, Kimiaei SA, Esmaeili H.. Relationship between Intensity of fear of Childbirth with choosing mode of delivery in Primiparous Women. Iran J Obstet Gynecol Infertil 2017;20(5):68–75. [Google Scholar]
33.Evans K, Rennick-Egglestone S, Cox S, Kuipers Y, Spiby H. Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis. J Med Internet Res. 2022;24(2):e28093. doi: 10.2196/28093 [DOI] [PMC free article] [PubMed] [Google Scholar]
34.Çankaya S, Şimşek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021;30(6):818–29. doi: 10.1177/1054773820916984 [DOI] [PubMed] [Google Scholar]
35.Melender HL. Fears and coping strategies associated with pregnancy and childbirth in Finland. J Midwifery Womens Health. 2002;47(4):256–63. doi: 10.1016/s1526-9523(02)00263-5 [DOI] [PubMed] [Google Scholar]
36.Nieminen K, Andersson G, Wijma B, Ryding E-L, Wijma K. Treatment of nulliparous women with severe fear of childbirth via the Internet: a feasibility study. Journal of Psychosomatic Obstetrics & Gynecology. 2016;37(2):37–43. doi: 10.3109/0167482X.2016.1140143 [DOI] [PubMed] [Google Scholar]
37.Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, et al. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014;41(4):384–94. doi: 10.1111/birt.12136 [DOI] [PMC free article] [PubMed] [Google Scholar]
38.Shahsavan F, Akbari N, Gharraee B, Abolghasemi J, Khedmat L. The effect of internet-based guided self-help cognitive-behavioral therapies on Iranian women’s psychological symptoms and preferred method of childbirth. Perspectives in Psychiatric Care. 2021;57(1):138–47. doi: 10.1111/ppc.12535 [DOI] [PubMed] [Google Scholar]
39.Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014;59(2):192–7. doi: 10.1111/jmwh.12075 [DOI] [PubMed] [Google Scholar]
40.Taheri Z, Mazaheri MA, Khorsandi M, Hassanzadeh A, Amiri M. Effect of Educational Intervention on Self-efficacy for Choosing Delivery Method among Pregnant Women in 2013. Int J Prev Med. 2014;5(10):1247–54. [PMC free article] [PubMed] [Google Scholar]
41.Stoll K, Edmonds JK, Hall WA. Fear of Childbirth and Preference for Cesarean Delivery Among Young American Women Before Childbirth: A Survey Study. Birth. 2015;42(3):270–6. doi: 10.1111/birt.12178 [DOI] [PubMed] [Google Scholar]
42.Sydsjö G, Blomberg M, Palmquist S, Angerbjörn L, Bladh M, Josefsson A. Effects of continuous midwifery labour support for women with severe fear of childbirth. BMC Pregnancy and Childbirth. 2015;15(1):115. doi: 10.1186/s12884-015-0548-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
43.Hildingsson I, Rubertsson C, Karlström A, Haines H. Caseload midwifery for women with fear of birth is a feasible option. Sex Reprod Healthc. 2018;16:50–5. doi: 10.1016/j.srhc.2018.02.006 [DOI] [PubMed] [Google Scholar]
44.Leighton C, Conroy M, Bilderback A, Kalocay W, Henderson JK, Simhan HN. Implementation and Impact of a Maternal-Fetal Medicine Telemedicine Program. Am J Perinatol. 2019;36(7):751–8. doi: 10.1055/s-0038-1675158 [DOI] [PubMed] [Google Scholar]
45.Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, Tam Y, et al. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. The Lancet Global Health. 2020;8(7):e901–e8. doi: 10.1016/S2214-109X(20)30229-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
46.Rural-Urban Differences In Severe Maternal Morbidity And Mortality In The US, 2007–15. Health Affairs. 2019;38(12):2077–85. doi: 10.1377/hlthaff.2019.00805 [DOI] [PubMed] [Google Scholar]
47.Sandborg J, Söderström E, Henriksson P, Bendtsen M, Henström M, Leppänen MH, et al. Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021;9(3):e26091. doi: 10.2196/26091 [DOI] [PMC free article] [PubMed] [Google Scholar]
48.Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, et al. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019;7(5):e10520. doi: 10.2196/10520 [DOI] [PMC free article] [PubMed] [Google Scholar]
49.The statistics of patients at Labor and the increase in natural childbirth at Baharlou Hospital. 2009 [http://194.225.51.22/baharlou.
50.Gharacheh M, Kalan ME, Khalili N, Ranjbar F. An increase in cesarean section rate during the first wave of COVID-19 pandemic in Iran. BMC Public Health. 2023;23(1):936. doi: 10.1186/s12889-023-15907-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
51.Sarbaz M, Mousavi Baigi SF, Manouchehri Monazah F, Dayani N, Kimiafar K. The trend of normal vaginal delivery and cesarean sections before and after implementing the health system transformation plan based on ICD-10 in the northeast of Iran: A cross-sectional study. Health Science Reports. 2023;6(3):e1131. doi: 10.1002/hsr2.1131 [DOI] [PMC free article] [PubMed] [Google Scholar]
52.Dadipoor S, Madani A, Alavi A, Roozbeh N, Safari Moradabadi A. A survey of the growing trend of caesarian section in Iran and the world: a review article. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2016;19(27):8–17. [Google Scholar]
53.WHO. Appropriate technology for birth. Lancet. 1985;2(8452):436–7. [PubMed]

PLoS One. doi: 10.1371/journal.pone.0293815.r001

Decision Letter 0

Hector Lamadrid-Figueroa

25 Jul 2023

PONE-D-23-17998The Effect of an mHealth Application based on Continuous Support and Education on Fear of Childbirth, Self-efficacy, and Birth Mode in Primiparous Women: A Randomized Controlled TrialPLOS ONE

Dear Dr. Khademioore,

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Reviewer #1: Overall, the authors provide a well-conceived, well-presented report of a randomized clinical trial to assess the impact of a mHealth intervention on Fear of Childbirth and other outcomes with important and significant findings. This is an important addition to the literature on interventions that may improve the quality of antenatal care and impact CS rates. There are however, a number of areas that need further clarification or modification.

Background:

First, it would be valuable to have greater contextual information on the setting in which the study took place. For example, at this particular hospital what is:

1. the overall volume of deliveries and cesarean section rate among all women presenting for care and during the period of the study (What was the impact of COVID?).

2. Who usually cares for women during prenatal care, birth and postnatally- midwives, physicians?

3. What is the usual number of ANC visits in general, and more specifically for the participants in the study what number of ANC visits did the intervention and control groups attend (results) ?

Methods:

Why was the intervention limited to women 18-40?

Line 99 …..the authors write with regard to inclusion criteria…..”as well as the ability to work with them, having access to the internet, not having chronic diseases and CS indications before or during pregnancy. The exclusion criteria were, emergency pregnancy conditions that required intervention (e.g., severe symptoms of COVID-19, placental abruption, fetus abnormalities, preeclampsia).” Did any of this occur after enrollment? What happened if these developed during the course of the study?

Line 202 The authors state that the researchers were available every day 7 am to 9 pm to answer questions posed in the intervention group. It appears that only 2 of the researchers are clinicians, did they respond to all of the questions? 7 days a week?

Sample size. The authors fail to describe how the data from the 2016 study by Gozde informed the sample size calculation- a basis for underlying prevalence of FOC?

Results:

The authors do not present the number of ANC visits attended in each group. Was there any difference in ANC attendance and may that have been a factor in outcomes? If overall there were very few in person visits in both groups due to COVID, then this study does not actually assess impact of the intervention vs standard care it is intervention vs decreased care.

Process information. Granted, there may be a secondary manuscript in the works that describes the actual dose of the intervention. However, the access to providers via the application to answer questions and respond to concerns is mentioned but not quantified. It would be useful to know how important this feature may be and how labor intensive. It would be valuable to have a sense of how frequently and for what reasons providers were contacted. Were there any referrals made to emergency services through this? Similarly, there is no data provided regarding the frequency with which women read the messages in a timely fashion and accessed the educational modules.

It would be valuable to have an overall sense of birth outcomes among the participants. Live births, stillbirths, early neonatal deaths, preterm birth

The authors maintained commendable follow up with no losses. I wonder what happened to women who developed pregnancy complications after enrollment- I presume they were kept in the intervention arm? Was this comparable in the groups?

Discussion.

Is there any information on the indications for CS? The authors rightly point out that the underlying CS rate is far above that considered appropriate for primiparous women. How might this have impacted the success of the intervention. Are there other interventions or movement to address the high CS rate in this setting? How might, or did COVID, impact this?

I am curious about the impact of the access to providers for questions and concerns. Is it possible to tease out how important the access compared to the educational components is?

The authors to not share their opinions on how this study should inform future work or if there are plans to study this intervention at scale in more of a real world setting. Granted this worked in a highly controlled setting where researchers were available to respond to questions but it is unclear what would happen in a scaled intervention setting.

Data:

The authors do not make the data available.

Reviewer #2: This manuscript reports the results investigating the effect of an mHealth application based on continuous support and education on primiparous women who were fear of childbirth on self-efficacy and birth mode with a randomized controlled study. I have below minor comments.

Please make a clear statement about which measurement or outcome was used for sample size estimate. How to come with the difference of 21 and sd of 7.2 for that outcome? Pleas note, since the difference of 21 is very big but the variation is small, the n=35/group is far greater than a sample size that achieves 90% power at alpha=0.05.

Table 2, the unit of gestational age should be weeks.

Line 253, should “increase” be “decrease”?

Line 265, Should “Two” be “The”?

Reviewer #3: Thank you for an interesting paper to review. I think it is a well-written paper with a novel and important approach for pregnant families. Nevertheless, the analysis seems to be relatively simple. I highly recommend using a logistic regression model as a minimum and then presenting your new results.

**********

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Reviewer #3: No

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PLoS One. 2023 Nov 1;18(11):e0293815. doi: 10.1371/journal.pone.0293815.r002

Author response to Decision Letter 0

9 Aug 2023

Reviewers' comments:

Reviewer #1:

"Overall, the authors provide a well-conceived, well-presented report of a randomized clinical trial to assess the impact of a mHealth intervention on Fear of Childbirth and other outcomes with important and significant findings. This is an important addition to the literature on interventions that may improve the quality of antenatal care and impact CS rates. There are however, a number of areas that need further clarification or modification.

Background:

First, it would be valuable to have greater contextual information on the setting in which the study took place. For example, at this particular hospital what is:

1. the overall volume of deliveries and cesarean section rate among all women presenting for care and during the period of the study (What was the impact of COVID?).

2. Who usually cares for women during prenatal care, birth and postnatally- midwives, physicians?

3. What is the usual number of ANC visits in general, and more specifically for the participants in the study what number of ANC visits did the intervention and control groups attend (results) ?"

Authors' Response: Thank you for your valuable feedback and the thorough review of our manuscript. We highly appreciate your insightful comments.

We acknowledge the importance of providing more conceptual information on the study setting. However, as the other related information is mentioned in the Methods and Discussion section, we also added points raised in numbers 1-3 in a related section to enhance the conciseness and clarity of the manuscript, and we hope these changes are satisfactory. The related sections now read as follows:

"According to the latest statistics available to the public, in Baharlou Hospital, there are approximately 350 births each month, comprising 38% CS (1). Although compared to the pre-pandemic period, the rate of CS increased during the COVID-19 pandemic (2), the high rate of CS in Iran has always been a challenge in the field of maternal health."

"The routine prenatal care in Iran includes up to 8 prenatal visits, which in the study site would be provided to all pregnant individuals by midwives and obstetricians. Routine prenatal care includes regular visits to monitor women and fetal health."

We also explained more about the number of antenatal care (ANC) visits in the study in the following comments.

"Methods:

Why was the intervention limited to women 18-40?"

Authors' Response: Our study's primary focus was on low-risk pregnancies. As a result, we excluded adolescent pregnancies (under 18 years old) and pregnancies in older age groups that are at higher risk of pregnancy complications and need medical interventions. Based on the result of this study, the age range of participants included in the analysis was limited to 18-33 years. This age range is considered low risk for pregnancies, and we attribute this to our study's emphasis on primiparous women, who typically have a lower mean age than multiparous women.

"Line 99 …..the authors write with regard to inclusion criteria….." as well as the ability to work with them, having access to the internet, not having chronic diseases and CS indications before or during pregnancy. The exclusion criteria were, emergency pregnancy conditions that required intervention (e.g., severe symptoms of COVID-19, placental abruption, fetus abnormalities, preeclampsia)." Did any of this occur after enrollment? What happened if these developed during the course of the study?"

Authors' Response: We specified these exclusion criteria in our protocol, and participants meeting these conditions were to be excluded from the study. The rationale behind these exclusions was that these conditions involve severe complications requiring emergency care, making them unsuitable for our intervention. Additionally, such conditions may lead to heightened anxiety and fear among individuals.

However, none of these conditions occurred among our participants. One possible reason for this is our eligibility criteria, which excluded high-risk pregnancies. In addition, many of these conditions could have arisen before the 26th week of gestation, when the eligibility criteria were assessed, resulting in the non-recruitment of participants who developed these conditions for the study. We have also documented these details in our CONSORT flow diagram (Figure 1).

"Line 202 The authors state that the researchers were available every day 7 am to 9 pm to answer questions posed in the intervention group. It appears that only 2 of the researchers are clinicians, did they respond to all of the questions? 7 days a week?"

Authors' Response: Except for our statistician (AK), the other three authors (SK, EE, and SM) are a certified midwife, a doctor of reproductive health (MSc in Midwifery), and an obstetrician and gynecologist. They are fully capable and eligible to address participants' pregnancy-related questions.

One of the most essential concepts of our intervention is continuous care, which is why the researchers offered uninterrupted support throughout the week, and the researchers answered any questions that might have been raised based on the educational content or general questions regarding their pregnancies, such as the number of in-person visits needed or specific types of food that should be avoided, etc.

"Sample size. The authors fail to describe how the data from the 2016 study by Gozde informed the sample size calculation- a basis for underlying prevalence of FOC?"

Authors' Response: Thank you for bringing this to our attention. We appreciate your comment and acknowledge that it is necessary to describe how the cited paper was used to estimate the sample size, outcome, and scale used.

The mean difference in fear of childbirth on the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) in the intervention and control group in the cited paper was used to estimate the sample size. We have updated the manuscript and included this information.

"Results:

Authors' Response: This is a very interesting point that you brought up. However, capturing the number of ANC visits was beyond the scope of this study. In addition, we want to clarify that our intervention was not intended to substitute in-person ANC visits; it was completely independent of ANC visits and served a different purpose. While we provided continuous care and addressed participants' pregnancy-related questions, we never offered formal ANC procedures such as prescribing medication, requesting screenings, sonograms, or lab tests. As a result, we assume both groups had a similar chance of missing their ANC visits due to any reason and, more specifically, because of the COVID-19 pandemic.

Additionally, it is essential to consider the study timeline. Our research was conducted from February to April. During almost half of the study, COVID-19 had not completely taken over Iran and affected routine care. However, we confirm that antenatal care was continuously offered in the prenatal clinic of the study site, even during the pandemic.

"Process information. Granted, there may be a secondary manuscript in the works that describes the actual dose of the intervention. However, the access to providers via the application to answer questions and respond to concerns is mentioned but not quantified. It would be useful to know how important this feature may be and how labor intensive. It would be valuable to have a sense of how frequently and for what reasons providers were contacted. Were there any referrals made to emergency services through this? Similarly, there is no data provided regarding the frequency with which women read the messages in a timely fashion and accessed the educational modules."

Authors' Response: Thank you for your attention to detail. In this current manuscript, we have presented all the data we collected on this intervention.

Considering the multifactorial pathway of fear of childbirth, our intervention included various components to address the diverse factors contributing to fear in pregnant individuals. During the study's design stage, we aimed for a complex intervention, believing that the successful reduction in fear of childbirth resulted from all the intervention components working together. At this stage of testing this new intervention, our primary goal was not to examine the isolated effects of each component, including education and continuous support provided by a care provider to answer questions.

It is important to clarify that this randomized controlled trial was conducted as part of a master's degree thesis with limited budget and time constraints, which unfortunately did not allow us to expand our work and collect more data. However, we totally agree on the importance of collecting more data on each aspect of the intervention and now that the results of this work have shown the possibility of success in reducing fear of childbirth, further comparative research are needed to build upon these findings to determine the most successful component, labor intensiveness (cost-effectiveness) and even explore women's perspectives through qualitative research before implementing the intervention in real-world settings. As previously mentioned, our intervention was not intended as an alternative to antenatal care, but rather as an addition to it. Similar to any educational content our intervention also needed a feature to answer questions raised by our educational material.

Furthermore, although we were prepared to refer participants in case of an emergency, no such contacts were made during the study period. We added this information to the manuscript.

Lastly, in our manuscript, we have addressed your last question:

"The application's educational content was designed for eight weeks in a way that between 3-4 short messages were sent to women on a daily basis." and "The researcher could track the women's activities in the application, and in case the women had not use the application for more than two days, a reminder was sent to follow them up."

"It would be valuable to have an overall sense of birth outcomes among the participants. Live births, stillbirths, early neonatal deaths, preterm birth"

Authors' Response: It would indeed be valuable information and an addition to the literature, making it a potential focus for future studies. However, it is important to note that the child outcome was not the objective of this study. Our main emphasis was on maternal outcomes, specifically fear of childbirth, self-efficacy, and childbirth mode. Child outcomes were not listed from the beginning in our ethics approval and protocol, and as a result, were not captured in our data.

"The authors maintained commendable follow up with no losses. I wonder what happened to women who developed pregnancy complications after enrollment- I presume they were kept in the intervention arm? Was this comparable in the groups?"

Authors' Response: As mentioned in the first paragraph of the Results section and illustrated in our CONSORT diagram, we did not experience any loss to follow-up or exclusion due to severe pregnancy complications requiring further medical attention and all participants who were initially enrolled were included in the final analysis. Our reasoning behind this decision was explained earlier in response to your previous question regarding exclusion criteria.

"Discussion.

Authors' Response: Thank you for raising this interesting point. The C-section rate in Iran has seen a significant increase over the years, rising from 35% in 2005 to 48% in 2014 and even more in private settings (3), which is considerably high compared to the WHO recommendation. This high rate of C-sections is a critical healthcare issue in the system and has been the subject of investigation and interventions to address this concern. For example, in governmental hospitals, elective C-sections are not possible based on maternal request. However, at the time of our study, no other intervention was ongoing with the purpose of reducing C-sections at the study site. It is important to note that the high rate of C-sections is not specific to our study setting; rather, it is prevalent in many hospitals. Considering this context, we view our intervention as successful in reducing the number of C-sections in the intervention group compared to the control group.

As our study is a governmental hospital, the indication for primary C-sections is fetal distress or maternal emergencies. However, recording the specific indication of C-sections study was beyond the scope of our study.

Regarding the impact of COVID-19 on the C-section rate, it is essential to clarify that none of our participants suffered from COVID-19 infection, and they would have been excluded if they had. Therefore, based on the results of this study, we cannot draw conclusions about the specific impact of COVID-19 on the C-section rate.

Nonetheless, we agree that this could be an interesting and multifactorial aspect to investigate in future research, and we have included it as an implication for future studies in our manuscript.

"I am curious about the impact of the access to providers for questions and concerns. Is it possible to tease out how important the access compared to the educational components is?"

Authors' Response: As we comprehensively explained above, we believe our intervention is effective as a composite of different components and did not capture the effect of each component separately. However, we strongly suggest future studies take this into consideration and have added this concern to our implications section in the manuscript.

"The authors to not share their opinions on how this study should inform future work or if there are plans to study this intervention at scale in more of a real world setting. Granted this worked in a highly controlled setting where researchers were available to respond to questions but it is unclear what would happen in a scaled intervention setting."

Authors' Response: Based on the findings of our study and your valuable comments regarding other variables that are better to consider when investigating the effect of this intervention, such as access to ANC, child outcome, and each component of the intervention, we added a section under the implications for future research to inform researchers.

We also provided information for discussing the limitations and considerations for scaling up the intervention, including how the availability of researchers in the controlled setting might differ from a real-world scenario.

"Implications for future research

In this study, participants received continuous support for addressing their queries throughout the week. However, replicating such personalized attention on a larger scale could be challenging. Real-world implementation might lack sufficient research personnel, potentially affecting intervention quality and adherence. Future research should investigate each component of our study intervention. Additionally, strategies to bridge the gap between controlled settings and real-world scenarios during scaling up need to be explored to maintain intervention quality.

Future studies are also needed to investigate the effects of this study's intervention by considering additional variables such as the number of antenatal care visits and child outcomes, including stillbirth and preterm birth. Recruiting multiparous and primiparous into future research can also be another area before implementing this study intervention in real settings."

"Data:

The authors do not make the data available."

Authors' Response: We confirm that all the data collected in this study has been thoroughly presented within the manuscript, including the text, tables, and figures.

However, as the study was conducted in a single center and within a relatively short timeframe, there is a potential risk of participant identification if the data set will make publicly available. Considering the PLOS ONE policy, "For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared, we allow authors to make their data sets available upon request", due to the restrictions regarding participant identification, the data set will be available upon request from the corresponding author.

Reviewer #2:

"This manuscript reports the results investigating the effect of an mHealth application based on continuous support and education on primiparous women who were fear of childbirth on self-efficacy and birth mode with a randomized controlled study. I have below minor comments.

Authors' Response: We appreciate your attention to detail and input regarding the sample size estimation. The cited paper used an intervention similar to our study's intervention; therefore, we used their study as a basis for calculating the minimum fear of childbirth score difference between the intervention and control groups. According to Gözde Birsbir et al.'s (2016), the difference in FOC between groups post-intervention was 21 scores (m i = 25.5, m c= 46.5).

With regard to your second point, we appreciate that you captured this point. The SD mentioned in the manuscript was the differences of the SD between the two groups based on the study used for sample size calculation (s i=18.2 , s c=25.4). We have revised the manuscript to eliminate any confusion and provide a clearer statement regarding the sample size calculation.

Also, our sample size calculation is noted below:

Given the:

α=0.05

β=0.9

μ1=25.5

μ2=46.5

s1=18.2

s2=25.4

We calculate the sample size using the below formula.

n=(〖( Z_(1-α⁄2)+ Z_(1-β))〗^2.(S_1^2+S_2^2))/(μ_1- μ_1 )^2

n=(〖( 1.96 - (-1.28)〗^2.(〖18.2〗^2+〖25.4〗^2))/(25.5- 46.5)^2

Therefore, we estimated to have 35 participants in each group.

"Table 2, the unit of gestational age should be weeks."

Authors' Response: Thank you for capturing this. The unit has been corrected.

Line 253, should "increase" be "decrease"?

Authors' Response: The correct word is "increase." This accurately reflects that the gap between the intervention and control groups in terms of fear of childbirth scores widened as time progressed, indicating a stronger and more significant effect of the intervention. We appreciate your keen observation, and to avoid confusion, we have added a summary to emphasize this aspect. We also added a figure to visualize the change in FOC in the intervention and control groups in different time points of the study.

"Line 265, Should "Two" be "The"?"

Authors' Response: Thank you again for your input, and we have corrected the title.

Reviewer #3:

"Thank you for an interesting paper to review. I think it is a well-written paper with a novel and important approach for pregnant families. Nevertheless, the analysis seems to be relatively simple. I highly recommend using a logistic regression model as a minimum and then presenting your new results."

Authors' Response: Thank you sincerely for taking the time to review our manuscript.

We acknowledge your concern regarding our analysis. For our secondary outcome, we agree that we can add more analysis and have included a logistic regression to estimate the odds of CS in the intervention group compared to the control group. The results have been added to the manuscript. Regarding the primary outcome, FOC, we opted for a generalized linear model (repeated-measures ANOVA) due to the longitudinal nature of our data. This approach allowed us to analyze the outcome (FOC) measured over time on the same individuals at different time points (baseline, after 8 weeks, and after childbirth). The repeated-measures ANOVA effectively accounts for the correlation between these data points.

Furthermore, it is worth noting that ANOVA can indeed be seen as a specific case of regression analysis. In our study, we chose the repeated-measures ANOVA method because it offered us the ability to handle within-subject variability and gain valuable insights into the changes over time. By utilizing repeated-measures ANOVA, we were able to capture the temporal evolution of FOC in both the intervention and control groups.

While adding a regression analysis might yield similar results, we believe that the repeated-measures ANOVA was the most appropriate choice for our study's objectives and data structure. It allowed us to examine the effects of time and group on FOC, while also accounting for the repeated measurements within the same individuals.

We hope this explanation clarifies our analysis rationale, and we are open to any further suggestions or inquiries you may have.

References

1. The statistics of patients at Labor and the increase in natural childbirth at Baharlou Hospital. 2009 [Available from: http://194.225.51.22/baharlou].

2. Gharacheh M, Kalan ME, Khalili N, Ranjbar F. An increase in cesarean section rate during the first wave of COVID-19 pandemic in Iran. BMC Public Health. 2023;23(1):936.

3. Shahshahan Z, Heshmati B, Akbari M, Sabet F. Caesarean section in Iran. The Lancet. 2016;388(10039):29-30.

Attachment

Submitted filename: Response to Reviewers.docx

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PLoS One. doi: 10.1371/journal.pone.0293815.r003

Decision Letter 1

Hector Lamadrid-Figueroa

29 Aug 2023

PONE-D-23-17998R1The Effect of an mHealth Application based on Continuous Support and Education on Fear of Childbirth, Self-efficacy, and Birth Mode in Primiparous Women: A Randomized Controlled TrialPLOS ONE

Dear Dr. Khademioore,

Please submit your revised manuscript by Oct 13 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Hector Lamadrid-Figueroa, MD, ScD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

Please address outstanding issues raised by reviewers 1 and 3.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: (No Response)

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: (No Response)

Reviewer #3: No

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

Reviewer #2: (No Response)

Reviewer #3: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

Reviewer #2: (No Response)

Reviewer #3: Yes

**********

6. Review Comments to the Author

Reviewer #1: The authors have done a good job in responding to the majority of my prior comments and I appreciate their efforts.

There remain however, a couple of outstanding questions and suggestions.

1. Methods. It is important that the methods are described in such a way that the intervention could be replicated. After learning that this is a Master’s project, I am left wondering who and how the educational resources were created?- this is a very labor intensive effort. Are the videos, messages, and images all original content? I would like to know how many videos, images, texts were created or included? This can be quantified and added to table 1. If the program linked to any pre-existing videos or materials, they should be referenced.

2. In the Methods section titled, “Continuous support and engagement of women:”, where the authors state (pg 11 line 205) “to provide women with an accessible source of information about their pregnancy and childbirth decisions"…The authors could clarify that the support did not include any prescription of medications or referrals for labs or testing of any kind.

3. I understand that the project did not have the resources to analyze frequency and type of contacts (dose and content of support messaging) with healthcare providers. However, I think this is an important issue for discussion in the limitations/future research section to add a statement acknowledging that frequency and content of support from obstetric providers and use of messaging were not measured. If the authors are able to add any assessment in the limitations section about how frequently they were contacted- i.e. -on average providers estimated they were contacted 1-5 times per day, 20 times a day, once a week…..anything would help.

4. On pg 20 line 349- Future research -need to consider not availability of “research personnel” but rather availability of qualified obstetric providers who can provide the education and advice needed.

Reviewer #2: (No Response)

Reviewer #3: Thank you for addressing all of our comments. However, I believe that your statistical analysis could be more robust by utilizing logistic regression models instead of ANOVA. Your statistical advisor should be likely aware that a logistic regression can be employed for any longitudinal study to measure the effects while controlling for potential confounders. An alternative model you could use to adjust is a Poisson model. Although, you have made an effort to include one logistic regression model in your analysis. Just make sure to incorporate a table presenting these results. This will ensure clarity on the variables you've included for adjustment. If the limits on tables/word count prevent this, consider at least mentioning in your results section which variables you used for adjustment and add this table in the Supporting information section.

In line 227: Please consider to add the words "A logistic regression MODEL was also PERFORMED to estimate the odds of CS in the intervention group..." to complete your sentence.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

**********

PLoS One. 2023 Nov 1;18(11):e0293815. doi: 10.1371/journal.pone.0293815.r004

Author response to Decision Letter 1

21 Sep 2023

Reviewer #1:

“Reviewer #1: The authors have done a good job in responding to the majority of my prior comments and I appreciate their efforts. There remain however, a couple of outstanding questions and suggestions.”

“1. Methods. It is important that the methods are described in such a way that the intervention could be replicated. After learning that this is a Master’s project, I am left wondering who and how the educational resources were created? - this is a very labor intensive effort. Are the videos, messages, and images all original content? I would like to know how many videos, images, texts were created or included? This can be quantified and added to table 1. If the program linked to any pre-existing videos or materials, they should be referenced.”

Authors' Response: Thank you for your comment. Over the past years, Iran has witnessed a range of initiatives aimed at producing health-related materials across various fields. The first author of this paper (SK) has actively participated in such endeavors, particularly in the field of midwifery, with the objective of providing her patients with the most up-to-date, evidence-informed recommendations. Additionally, although creating content for a mHealth application can be labor-intensive, these materials can be used many times, making mHealth applications more cost-effective in the long term. In this project, the research team meticulously curated and organized existing materials while also incorporating fresh information from diverse scientific sources, spanning from textbooks to comprehensive Cochrane systematic reviews. We have included the list of references used in the method section. It's important to note that we refrained from utilizing any pre-existing materials to uphold copyright integrity. The number of videos, images, and text messages has been added to Table 1.

“2. In the Methods section titled, “Continuous support and engagement of women:”, where the authors state (pg 11 line 205) “to provide women with an accessible source of information about their pregnancy and childbirth decisions"…The authors could clarify that the support did not include any prescription of medications or referrals for labs or testing of any kind.”

Authors' Response: Thanks for keen your comment. We have provided this important information to our “Continuous support and engagement of women” section.

Now it reads:

“However, this feature was not intended to substitute the usual antenatal care, and no medication prescriptions, requesting laboratory tests, or imaging were offered via our mHealth.”

“3. I understand that the project did not have the resources to analyze frequency and type of contacts (dose and content of support messaging) with healthcare providers. However, I think this is an important issue for discussion in the limitations/future research section to add a statement acknowledging that frequency and content of support from obstetric providers and use of messaging were not measured. If the authors are able to add any assessment in the limitations section about how frequently they were contacted- i.e. -on average providers estimated they were contacted 1-5 times per day, 20 times a day, once a week…..anything would help.”

Authors' Response: We have indeed recognized the importance of measuring the frequency and content of support received by participants during the intervention. We have added a paragraph in the limitations section to acknowledge the significance of this aspect. Since we did not collect precise data on the frequency of interactions with healthcare providers via the application, we refrained from providing specific statistics regarding the frequency of contact but instead emphasized its importance for future research. This key point has been highlighted in our discussion. We appreciate your insightful feedback, which has contributed to a more comprehensive understanding of the study's limitations and future research directions.

This section now reads:

“In this study we did not capture the frequency and nature of interactions between participants and healthcare providers who delivered the continues support feature of mHealth intervention. Consequently, the specific types of support, the average frequency of provider contact (such as interactions per day or week), and the potential impact of these interactions on maternal health outcomes remain unexplored in this study. Future research is needed to delve deeper into understanding the dynamics and potential benefits of such interactions for expecting mothers.”

Authors' Response: Thank you for capturing this. We now used the term 'sufficient qualified healthcare professionals in the field of obstetrics' to better convey our message.

Reviewer #3

“Reviewer #3: Thank you for addressing all of our comments. However, I believe that your statistical analysis could be more robust by utilizing logistic regression models instead of ANOVA. Your statistical advisor should be likely aware that a logistic regression can be employed for any longitudinal study to measure the effects while controlling for potential confounders. An alternative model you could use to adjust is a Poisson model. Although, you have made an effort to include one logistic regression model in your analysis. Just make sure to incorporate a table presenting these results. This will ensure clarity on the variables you've included for adjustment. If the limits on tables/word count prevent this, consider at least mentioning in your results section which variables you used for adjustment and add this table in the Supporting information section.”

Authors' Response: Thank you for your meticulous feedback on our analysis and results section. We have significantly revised the results section to incorporate your suggestions. Now we have presented the result of regression models for all of our outcomes.

To elaborate on our rationale for employing a linear regression model in our analyses, as opposed to logistic regression, we considered the continuous nature of the outcome variables (fear of childbirth and self-efficacy score). Given that our study's primary objective was to capture the degree of change in fear of childbirth and self-efficacy scores, we opted not to categorize our outcome or investigate the intervention's effect on change between categories. This approach allowed us to better account for the variability of outcomes within groups. Additionally, there is no established threshold to categorize self-efficacy from a continuous measure into a categorical variable [1]. Previous research has also treated fear of childbirth and self-efficacy as continuous variables, ensuring improved comparability of our results with existing literature.

Regarding adjustments in our model, the randomization in our study design was designed to balance known and unknown confounders between the two groups. Furthermore, our descriptive analysis in Table 1 revealed no statistically significant differences in known confounders such as age, education, and income levels, and the minor variations between groups were not a cause for concern. In addition, baseline scores for fear of childbirth and self-efficacy were balanced. This suggests the success of our randomization process. Therefore, initially, we presented unadjusted models in our results, as these confounders were anticipated to have a negligible impact on the outcomes [2]. However, in line with your suggestion, we conducted adjusted models accounting for age, income, education, and baseline outcome scores, and we have included this information in the supplementary material. Additionally, in the results section, we have clarified which variables were used for adjusted models, highlighting that the results are presented with these variables held constant.

1- Naggara, O., Raymond, J., Guilbert, F., Roy, D., Weill, A., & Altman, D. G. (2011). Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR. American journal of neuroradiology, 32(3), 437–440. https://doi.org/10.3174/ajnr.A2425

2- Vickers A J, Altman D G. Analysing controlled trials with baseline and follow up measurements BMJ 2001; 323 :1123 doi:10.1136/bmj.323.7321.1123

“In line 227: Please consider to add the words "A logistic regression MODEL was also PERFORMED to estimate the odds of CS in the intervention group..." to complete your sentence.”

Authors' Response: Thank you for capturing this. We have revised it accordingly.

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Click here for additional data file.^{(20.5KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0293815.r005

Decision Letter 2

Hector Lamadrid-Figueroa

20 Oct 2023

The Effect of an mHealth Application based on Continuous Support and Education on Fear of Childbirth, Self-efficacy, and Birth Mode in Primiparous Women: A Randomized Controlled Trial

PONE-D-23-17998R2

Dear Dr. Khademioore,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Hector Lamadrid-Figueroa, MD, ScD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0293815.r006

Acceptance letter

Hector Lamadrid-Figueroa

23 Oct 2023

PONE-D-23-17998R2

The Effect of an mHealth Application based on Continuous Support and Education on Fear of Childbirth, Self-efficacy, and Birth Mode in Primiparous Women: A Randomized Controlled Trial

Dear Dr. Khademioore:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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on behalf of

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PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 File. Protocol of the study.

(DOCX)

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S2 File. CONSORT checklist.

(DOC)

Click here for additional data file.^{(220KB, doc)}

S3 File. S1-S4 Tables.

(DOCX)

Click here for additional data file.^{(18.7KB, docx)}

Attachment

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Data Availability Statement

[pone.0293815.ref001] 1.Shakarami A, Mirghafourvand M, Abdolalipour S, Jafarabadi MA, Iravani M. Comparison of fear, anxiety and self-efficacy of childbirth among primiparous and multiparous women. BMC Pregnancy and Childbirth. 2021;21(1):642. doi: 10.1186/s12884-021-04114-8 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref002] 2.Wijma K, Wijma B, editors. A Woman Afraid to Deliver: How to Manage Childbirth Anxiety2017.

[pone.0293815.ref003] 3.O’Connell MA, Leahy‐Warren P, Khashan AS, Kenny LC, O’Neill SM. Worldwide prevalence of tocophobia in pregnant women: systematic review and meta‐analysis. Acta obstetricia et gynecologica Scandinavica. 2017;96(8):907–20. doi: 10.1111/aogs.13138 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref004] 4.Dencker A, Nilsson C, Begley C, Jangsten E, Mollberg M, Patel H, et al. Causes and outcomes in studies of fear of childbirth: A systematic review. Women and birth: journal of the Australian College of Midwives. 2019;32(2):99–111. doi: 10.1016/j.wombi.2018.07.004 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref005] 5.Laursen M, Johansen C, Hedegaard M. Fear of childbirth and risk for birth complications in nulliparous women in the Danish National Birth Cohort. BJOG: An International Journal of Obstetrics & Gynaecology. 2009;116(10):1350–5. doi: 10.1111/j.1471-0528.2009.02250.x [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref006] 6.Serçekuş P, Okumuş H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009;25(2):155–62. doi: 10.1016/j.midw.2007.02.005 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref007] 7.Salomonsson B, Gullberg MT, Alehagen S, Wijma K. Self-efficacy beliefs and fear of childbirth in nulliparous women. Journal of Psychosomatic Obstetrics & Gynecology. 2013;34(3):116–21. doi: 10.3109/0167482X.2013.824418 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref008] 8.Ip W-Y, Tang CS, Goggins WB. An educational intervention to improve women’s ability to cope with childbirth. Journal of Clinical Nursing. 2009;18(15):2125–35. doi: 10.1111/j.1365-2702.2008.02720.x [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref009] 9.Sandall J, Tribe RM, Avery L, Mola G, Visser GH, Homer CS, et al. Short-term and long-term effects of caesarean section on the health of women and children. Lancet. 2018;392(10155):1349–57. doi: 10.1016/S0140-6736(18)31930-5 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref010] 10.O’Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O’Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021;7(7):Cd013321. doi: 10.1002/14651858.CD013321.pub2 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref011] 11.Striebich S, Mattern E, Ayerle GM. Support for pregnant women identified with fear of childbirth (FOC)/tokophobia—A systematic review of approaches and interventions. Midwifery. 2018;61:97–115. doi: 10.1016/j.midw.2018.02.013 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref012] 12.Bayrampour H, Trieu J, Tharmaratnam T. Effectiveness of eHealth Interventions to Reduce Perinatal Anxiety: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019;80(1). doi: 10.4088/JCP.18r12386 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref013] 13.Mupinga DM. Distance education in high schools: Benefits, challenges, and suggestions. The clearing house: a journal of educational strategies, Issues and Ideas. 2005;78(3):105–9. [Google Scholar]

[pone.0293815.ref014] 14.O’Brien E, Rauf Z, Alfirevic Z, Lavender T. Women’s experiences of outpatient induction of labour with remote continuous monitoring. Midwifery. 2013;29(4):325–31. doi: 10.1016/j.midw.2012.01.014 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref015] 15.Rauf Z, O’Brien E, Stampalija T, Ilioniu FP, Lavender T, Alfirevic Z. Home labour induction with retrievable prostaglandin pessary and continuous telemetric trans-abdominal fetal ECG monitoring. PLoS One. 2011;6(11):e28129. doi: 10.1371/journal.pone.0028129 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref016] 16.Sandall J, Soltani H, Gates S, Shennan A, Devane D. Midwife-led continuity models versus other models of care for childbearing women. Cochrane Database Syst Rev. 2016;4:Cd004667. doi: 10.1002/14651858.CD004667.pub5 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref017] 17.Hanach N, de Vries N, Radwan H, Bissani N. The effectiveness of telemedicine interventions, delivered exclusively during the postnatal period, on postpartum depression in mothers without history or existing mental disorders: A systematic review and meta-analysis. Midwifery. 2021;94:102906. doi: 10.1016/j.midw.2020.102906 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref018] 18.Wigert H, Nilsson C, Dencker A, Begley C, Jangsten E, Sparud-Lundin C, et al. Women’s experiences of fear of childbirth: a metasynthesis of qualitative studies. International Journal of Qualitative Studies on Health and Well-being. 2020;15(1):1704484. doi: 10.1080/17482631.2019.1704484 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref019] 19.Zengin H, Bafali IO, Caka SY, Tiryaki O, Cinar N. Childbirth and Postpartum Period Fear and the Related Factors in Pregnancy. Journal of the College of Physicians and Surgeons—Pakistan: JCPSP. 2020;30(2):144–8. doi: 10.29271/jcpsp.2020.02.144 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref020] 20.Schnitman G, Wang T, Kundu S, Turkdogan S, Gotlieb R, How J, et al. The role of digital patient education in maternal health: A systematic review. Patient Education and Counseling. 2021. doi: 10.1016/j.pec.2021.06.019 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref021] 21.Richens Y, Hindley DC, Lavender T. A national online survey of UK maternity unit service provision for women with fear of birth. British Journal of Midwifery. 2015;23(8):574–9. [Google Scholar]

[pone.0293815.ref022] 22.Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998;19(2):84–97. doi: 10.3109/01674829809048501 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref023] 23.Mortazavi F. Validity and reliability of the Farsi version of Wijma delivery expectancy questionnaire: an exploratory and confirmatory factor analysis. Electron Physician. 2017;9(6):4606–15. doi: 10.19082/4606 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref024] 24.Lowe NK. Self-efficacy for labor and childbirth fears in nulliparous pregnant women. Journal of Psychosomatic Obstetrics & Gynecology. 2000;21(4):219–24. doi: 10.3109/01674820009085591 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref025] 25.Khorsandi M, Ghofranipour F, Faghihzadeh S, Hidarnia A, Bagheban AA, Aguilar-Vafaie ME. Iranian version of childbirth self-efficacy inventory. Journal of clinical nursing. 2008;17(21):2846–55. doi: 10.1111/j.1365-2702.2008.02385.x [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref026] 26.Gökçe İsbir G, İnci F, Önal H, Yıldız PD. The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study. Applied Nursing Research. 2016;32:227–32. doi: 10.1016/j.apnr.2016.07.013 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref027] 27.Marshall JE, Raynor MD. Myles’ Textbook for Midwives E-Book: Myles’ Textbook for Midwives E-Book. London, UNITED KINGDOM: Elsevier Health Sciences; 2014. [Google Scholar]

[pone.0293815.ref028] 28.Torkestani F, Dokht-Abdini M, Radpouyan L, Rahimi Ghosbe S, Hadi Pour Jahromi L, Bakhshande M, et al. National guide to maternal and neonatal services: Ministry of Health, Treatment and Medical Education; 2009. [Google Scholar]

[pone.0293815.ref029] 29.Cunningham FG, Leveno KJ, Bloom SL, Spong CY, Dashe JS, Hoffman BL, et al. Williams obstetrics: McGraw-Hill Medical; New York; 2014. [Google Scholar]

[pone.0293815.ref030] 30.Charles J Lockwood M, MHCMUrania Magriples, MD. Prenatal care: Patient education, health promotion, and safety of commonly used drugs [https://www.uptodate.com/contents/prenatal-care-patient-education-health-promotion-and-safety-of-commonly-used-drugs.

[pone.0293815.ref031] 31.Kananikandeh S, Amin Shokravi F, Mirghafourvand M, Jahanfar S. Factors of the childbirth fear among nulliparous women in Iran. BMC Pregnancy and Childbirth. 2022;22(1):547. doi: 10.1186/s12884-022-04870-1 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref032] 32.Andaroon N KM, Kimiaei SA, Esmaeili H.. Relationship between Intensity of fear of Childbirth with choosing mode of delivery in Primiparous Women. Iran J Obstet Gynecol Infertil 2017;20(5):68–75. [Google Scholar]

[pone.0293815.ref033] 33.Evans K, Rennick-Egglestone S, Cox S, Kuipers Y, Spiby H. Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis. J Med Internet Res. 2022;24(2):e28093. doi: 10.2196/28093 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref034] 34.Çankaya S, Şimşek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021;30(6):818–29. doi: 10.1177/1054773820916984 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref035] 35.Melender HL. Fears and coping strategies associated with pregnancy and childbirth in Finland. J Midwifery Womens Health. 2002;47(4):256–63. doi: 10.1016/s1526-9523(02)00263-5 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref036] 36.Nieminen K, Andersson G, Wijma B, Ryding E-L, Wijma K. Treatment of nulliparous women with severe fear of childbirth via the Internet: a feasibility study. Journal of Psychosomatic Obstetrics & Gynecology. 2016;37(2):37–43. doi: 10.3109/0167482X.2016.1140143 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref037] 37.Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, et al. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014;41(4):384–94. doi: 10.1111/birt.12136 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref038] 38.Shahsavan F, Akbari N, Gharraee B, Abolghasemi J, Khedmat L. The effect of internet-based guided self-help cognitive-behavioral therapies on Iranian women’s psychological symptoms and preferred method of childbirth. Perspectives in Psychiatric Care. 2021;57(1):138–47. doi: 10.1111/ppc.12535 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref039] 39.Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014;59(2):192–7. doi: 10.1111/jmwh.12075 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref040] 40.Taheri Z, Mazaheri MA, Khorsandi M, Hassanzadeh A, Amiri M. Effect of Educational Intervention on Self-efficacy for Choosing Delivery Method among Pregnant Women in 2013. Int J Prev Med. 2014;5(10):1247–54. [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref041] 41.Stoll K, Edmonds JK, Hall WA. Fear of Childbirth and Preference for Cesarean Delivery Among Young American Women Before Childbirth: A Survey Study. Birth. 2015;42(3):270–6. doi: 10.1111/birt.12178 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref042] 42.Sydsjö G, Blomberg M, Palmquist S, Angerbjörn L, Bladh M, Josefsson A. Effects of continuous midwifery labour support for women with severe fear of childbirth. BMC Pregnancy and Childbirth. 2015;15(1):115. doi: 10.1186/s12884-015-0548-6 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref043] 43.Hildingsson I, Rubertsson C, Karlström A, Haines H. Caseload midwifery for women with fear of birth is a feasible option. Sex Reprod Healthc. 2018;16:50–5. doi: 10.1016/j.srhc.2018.02.006 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref044] 44.Leighton C, Conroy M, Bilderback A, Kalocay W, Henderson JK, Simhan HN. Implementation and Impact of a Maternal-Fetal Medicine Telemedicine Program. Am J Perinatol. 2019;36(7):751–8. doi: 10.1055/s-0038-1675158 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref045] 45.Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, Tam Y, et al. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. The Lancet Global Health. 2020;8(7):e901–e8. doi: 10.1016/S2214-109X(20)30229-1 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref046] 46.Rural-Urban Differences In Severe Maternal Morbidity And Mortality In The US, 2007–15. Health Affairs. 2019;38(12):2077–85. doi: 10.1377/hlthaff.2019.00805 [DOI] [PubMed] [Google Scholar]

[pone.0293815.ref047] 47.Sandborg J, Söderström E, Henriksson P, Bendtsen M, Henström M, Leppänen MH, et al. Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021;9(3):e26091. doi: 10.2196/26091 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref048] 48.Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, et al. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019;7(5):e10520. doi: 10.2196/10520 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref049] 49.The statistics of patients at Labor and the increase in natural childbirth at Baharlou Hospital. 2009 [http://194.225.51.22/baharlou.

[pone.0293815.ref050] 50.Gharacheh M, Kalan ME, Khalili N, Ranjbar F. An increase in cesarean section rate during the first wave of COVID-19 pandemic in Iran. BMC Public Health. 2023;23(1):936. doi: 10.1186/s12889-023-15907-1 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref051] 51.Sarbaz M, Mousavi Baigi SF, Manouchehri Monazah F, Dayani N, Kimiafar K. The trend of normal vaginal delivery and cesarean sections before and after implementing the health system transformation plan based on ICD-10 in the northeast of Iran: A cross-sectional study. Health Science Reports. 2023;6(3):e1131. doi: 10.1002/hsr2.1131 [DOI] [PMC free article] [PubMed] [Google Scholar]

[pone.0293815.ref052] 52.Dadipoor S, Madani A, Alavi A, Roozbeh N, Safari Moradabadi A. A survey of the growing trend of caesarian section in Iran and the world: a review article. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2016;19(27):8–17. [Google Scholar]

[pone.0293815.ref053] 53.WHO. Appropriate technology for birth. Lancet. 1985;2(8452):436–7. [PubMed]

PERMALINK

The effect of an mHealth application based on continuous support and education on fear of childbirth, self-efficacy, and birth mode in primiparous women: A randomized controlled trial

Sahar Khademioore

Elham Ebrahimi

Ahmad Khosravi

Shohreh Movahedi

Roles

Abstract

Background

Methods

Results

Conclusions

Trial registration

Introduction

Materials and methods

Study design and eligibility criteria

Outcomes

Measures

Sample size

Procedures

Fig 1. CONSORT flow diagram of the study.

Tele-midwifery application

Dimensions of intervention

Education

Table 1. Five components of educational content of Tele-midwifery application.

Continuous support and engagement of women

Statistical analyzes

Ethical considerations

Results

Table 2. Characteristics of the participants.

FOC

Table 3. Effect of mHealth application on FOC score in intervention group compared to control group at different time points (n = 70).

Fig 2. Comparison of FOC scores in intervention and control groups at baseline, after 8 weeks and after childbirth.

Childbirth self-efficacy

Table 4. Effect of mHealth application on self-efficacy score in intervention group compared to control group at baseline and 8 weeks after intervention (n = 70).

Birth mode

Discussion

Strengths and limitations of research

Implications for future research

Conclusion

Supporting information

Acknowledgments

Data Availability

Funding Statement

References

Decision Letter 0

Hector Lamadrid-Figueroa

Roles

Author response to Decision Letter 0

Decision Letter 1

Hector Lamadrid-Figueroa

Roles

Author response to Decision Letter 1

Decision Letter 2

Hector Lamadrid-Figueroa

Roles

Acceptance letter

Hector Lamadrid-Figueroa

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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