Association between maternal and neonatal outcomes and psychosocial risk levels in pregnant women: a convergent parallel mixed methods study protocol

Abstract

Background

Perinatal psychosocial health has gained significant attention due to its impact on maternal and neonatal health outcomes. Elevated rates of mental health disorders during pregnancy and the initial postpartum year, particularly pronounced in low- and middle-income countries (LMICs), have been consistently linked to women’s heightened exposure to psychosocial risk factors. In response to this evidence, the current investigation is designed to evaluate psychosocial risk status among pregnant women and to explore its associations with both maternal and neonatal outcomes, employing a convergent mixed-methods design.

Methods/design

A convergent parallel mixed‑methods design will be employed for this investigation. The quantitative strand comprises a prospective cohort study that will enroll 260 pregnant women at 12–14 weeks of gestation. Based on their ANRQ‑R total scores, participants will be divided into two groups: those scoring 23 or above (high‑risk) will form the exposed cohort, while those scoring below 23 (low‑risk) will constitute the non‑exposed cohort. Both groups will be followed prospectively until six weeks postpartum. At enrolment, a sociodemographic and obstetric characteristics form will be completed. A second data collection point at 31–34 weeks of gestation will involve administration of the Wijma Delivery Expectancy/Experience Questionnaire (W‑DEQ, version A), the Edinburgh Postnatal Depression Scale (EPDS), and the Pregnancy Experience Scale (PES). Postnatally, within six weeks after birth, the following instruments will be administered: a Maternal and Neonatal Outcomes Checklist, the EPDS, the Childbirth Experience Questionnaire version 2.0 (CEQ‑2), the Postpartum Specific Anxiety Scale Research Short‑Form, the Barkin Index of Maternal Functioning (BIMF), and a measure of Breastfeeding Self‑Efficacy. Running concurrently with the quantitative follow‑up, the qualitative phase will recruit participants through purposive sampling from both high‑ and low‑risk groups. Data will be generated via in‑depth, semi‑structured individual interviews using open‑ended questions, allowing for rich exploration of participants’ experiences. Finally, the findings from both the qualitative and quantitative strands will be integrated in the discussion section.

Discussion

Identifying psychosocially vulnerable mothers before the onset of mental health disorders during pregnancy, coupled with a deep understanding of the maternal and neonatal outcomes of these risk factors, can provide a roadmap for designing a healthcare system that preemptively safeguards maternal mental health. Furthermore, this approach can contribute to reducing healthcare system costs through timely screening, early intervention, and the effective management of psychosocial conditions.

Plain language summary

Contrary to past beliefs, mental health issues during pregnancy are as common as, and sometimes even more prevalent than, in the postpartum period. While pregnancy can be a vulnerable time for mental health, it also provides a unique “window of opportunity” for identifying and treating psychological and social challenges. For a mother who has experienced past trauma, pregnancy offers a chance to form a new, secure, and loving bond with her child—essentially providing a way to “rewrite” her own past experiences. Therefore, the objectives of this study include assessing psychosocial risk levels, determining their impact on maternal and neonatal outcomes, alongside an exploration of women’s perceived experiences of pregnancy, achieved by merging quantitative statistical data with in-depth qualitative accounts.

This research uses a multi-phase “mixed-methods” approach in three stages: 1. Quantitative Phase: We will examine how psychosocial risk levels during pregnancy relate to maternal outcomes (such as the pregnancy and childbirth experience, and depression) and newborn outcomes (such as low birth weight); 2. Qualitative Phase: We will conduct in-depth, personal interviews with women to understand their individual stories and perceptions; 3. Mixed Phase: We will merge the statistical findings with the personal insights from the interviews to create a complete and clear picture of the situation.

Given the lack of multifaceted screening tools and the critical gaps in prenatal mental health care, this research holds significant importance. It emphasizes the need for a proactive healthcare roadmap to safeguard maternal mental health, aligning with the goal of preventing adverse outcomes and ensuring comprehensive support for both mothers and newborns.

Background

Issues surrounding psychosocial factors during the perinatal period are of significant concern due to their potential impact on maternal and neonatal outcomes [1]. According to international studies, a considerable proportion of women (typically between 40% and 60%) have been identified as high-risk in terms of psychosocial risk factors [2, 3]. And these disorders are more prevalent in low- and middle-income countries. In these countries, 15.6% of women suffer from a mental disorder during pregnancy, and 19.8% experience it postpartum [4]. In Iran, a prospective study conducted during the perinatal period reported that approximately one-third of women (32.9%) experienced emotional abuse, 21.2% physical violence, 49.4% sexual coercion, and 6.3% injury [5]. Exposure to psychosocial stressors may correlate with negative maternal and neonatal consequences, such as impaired mother-infant bonding, negative effects on fetal and neonatal development [6, 7], deterioration of physical health, reduced quality of life, increased interpersonal distress [8], gestational hypertension [9], and neonatal admission to the NICU [10].

The experience of pregnancy is one of the outcomes that can be influenced by psychosocial factors surrounding pregnancy and childbirth. As a unique experience in a woman’s life, it is evaluated and measured using two criteria: “Hassles” (unpleasant experiences) and “Uplifts” (joyful experiences) [11]. Pregnant women perceived a positive experience when communicating with their spouse and receiving their support [12, 13], whereas they perceived a negative pregnancy experience when encountering any fear or anxiety regarding their pregnancy and delivery [14]. Conversely, research indicates that women receiving strong social support report more favorable pregnancy experiences, whereas those with limited support tend to have lower scores on measures of pregnancy experience [15]. Findings from a psychometric investigation revealed a moderate inverse relationship between happiness intensity and anxiety levels [16]. Additionally, mothers with lower anxiety had more positive pregnancy experiences [17], and consequently, mothers with joyful pregnancy experiences developed better bonding with their fetus [18]. Furthermore, negative experiences and emotions during pregnancy can spill over into other areas of life, such as work, and disrupt balance [19].

The impact of psychosocial factors sometimes continues into the labor and postpartum periods; even in women’s childbirth experiences, the traces of these factors are observed. Mental health, as a key factor that can have a long-term effect on the birth experience, can sometimes shape childbirth experiences that are not erased from a woman’s mind for years [20]. Factors such as stress, depression, anxiety during pregnancy, social support during pregnancy [21], and even smoking in the first trimester [22] can be predictors of a woman’s experience of her childbirth. Women with negative birth experiences are more prone to postpartum depression and anxiety [23]. In contrast, women with a healthy emotional state (especially those who had a support person during labor) had fewer negative birth experiences compared to emotionally unhealthy women [24]. Studies have also shown that women with positive birth experiences had lower rates of postpartum depression and experienced better psychological growth [25]. Conversely, women with negative birth experiences are more exposed to poor breastfeeding performance [26] and symptoms of anxiety and depression [27, 28].

Perinatal depression, a prevalent mental health condition during this period [29], can also be influenced by various psychological factors. For example, psychosocial risk factors such as exposure to Intimate Partner Violence (IPV) or violence by another male family member during pregnancy [30] and substance use (current or past experience) [31] can increase postpartum depression risk. In a review study, the prevalence of prenatal depression was higher in women who had been sexually abused in childhood [32], and their postpartum mental health and emotional bonding outcomes were affected by this issue [33]. However, receiving support from family and those around them led to a reduction in pregnancy and postpartum depression [34]. Meta-analytic evidence further indicates that antenatal depression is associated with approximately 40% higher odds of preterm birth and a 50% increased risk of low birth weight [35].

Birth weight can also be affected by psychosocial factors [36]. Pregnancy concerns and lack of support at home for working women [37], a history of domestic violence and mental health problems, alcohol consumption [38], substance use in pregnancy [39], pregnancy stress [40], and anxiety [41] are factors that can be associated with low birth weight.

Maternal postpartum anxiety represents another outcome potentially shaped by psychosocial influences. Evidence indicates that pregnant women report heightened anxiety levels when lacking emotional support [42], experiencing partner violence [43], or having a history of substance misuse [44]. Additional predictors of postpartum anxiety exacerbation include third‑trimester depression severity and obsessive‑compulsive symptoms [45], along with prior depression, earlier anxiety, abuse, and marital difficulties [46]. Meta‑analytic findings demonstrate that each unit increase in maternal anxiety corresponds to a 2.64‑fold rise in postpartum depression risk, and is further linked to a 37% reduction in breastfeeding likelihood [47]. Furthermore, research has shown that highly anxious mothers tend to exhibit greater fear of childbirth [48].

Fear of childbirth (FOC) is driven by high-risk psychosocial factors such as a history of violence [49], which can lead to adverse outcomes like increased requests for cesarean sections and reduced exclusive breastfeeding [50]. Similarly, maternal performance and breastfeeding success are negatively impacted by factors like intimate partner violence [5, 51], while other psychosocial risks such as depressive symptoms [52] are significant predictors of increased preterm birth rates [53, 54].

Identifying mental health issues during pregnancy is vital for maternal and neonatal outcomes [55], offering a unique opportunity to address and heal past traumas [56]. Despite the increasing importance of structural interventions [57–59], screening faces challenges such as social stigma and inconsistent clinical practices [60, 61], which can be mitigated through regular assessment. Global practices vary significantly: Europe lacks routine unified screening [62–64], the U.S. utilizes visual calendars that may lack generalizability [65, 66], and Australia employs time-intensive interviews [67, 68] that are impractical for low-resource settings where mental health is often underfunded [69]. Unlike traditional tools that focus only on current symptoms [70], the WHO recommends routine assessments that evaluate a mother’s lifetime psychosocial risk factors to identify vulnerability early [60, 64]. Consequently, the Antenatal Risk Questionnaire (ANRQ) was developed as a concise, user-friendly version of the original 23-item Australian tool [71] to fit busy clinical environments. The ANRQ was developed as a brief, 12-item clinical tool to assess key psychosocial domains, including childhood support, psychiatric history, partner support, and life stressors [2]. Its revised version, ANRQ-R (2021), incorporates mandatory screenings for domestic violence and substance abuse to provide a multi-dimensional, evidence-based framework for early risk identification [3]. In Iran, current maternity care lacks such specific risk-stratification tools, relying instead on basic binary questions and postpartum depression screening that fail to account for historical traumas or identify vulnerable mothers before crises occur [70]. Similar traditional models in Australia have been shown to result in high false-positive rates and clinical inefficiency [72], yet Iran lacks audits regarding the feasibility and acceptance of its current screening methods. Accordingly, a comprehensive instrument that encompasses a mother’s complete psychosocial background is urgently required, alongside prospective mixed-methods investigations aimed at enhancing understanding of how these risk factors influence maternal and neonatal outcomes. This need is underscored by the fact that existing Iranian research predominantly relies on retrospective or cross-sectional designs, which provide a lower level of evidence relative to cohort studies, and has yielded inconsistent findings [73, 74]. Therefore, this study will be the first to investigate the association between psychosocial risk levels and maternal and neonatal outcomes using a mixed-methods approach.

Objectives

The objectives of this study will be structured into three phases, including quantitative, qualitative, and mixed-methodology phases:

Objectives of the first phase: quantitative phase

1. To determine the difference in the mean pregnancy experience scores between the exposure (high psychosocial risk) and non-exposure (low psychosocial risk) groups at 31–34 weeks of gestation.

2. To determine the difference in the mean birth experience scores between the high-risk and low-risk groups at 4–6 weeks postpartum.

3. To determine the difference in the mean scores of prenatal and postpartum depressions between the high-risk and low-risk groups.

4. To determine the difference in the frequency of low birth weight between the high-risk and low-risk groups.

Objective of the second phase: qualitative phase

To elucidate women’s perceptions of their pregnancy experiences by comparing those with high and low psychosocial risk levels.

Objectives of the third phase: mixed phase

To provide an integrated interpretation of quantitative and qualitative findings, thereby facilitating a more comprehensive understanding of maternal and neonatal outcomes and pregnancy experiences among women with high and low psychosocial risk levels.

Methods/design

This investigation will apply a convergent parallel mixed-methods design, with data collection scheduled from June 2026 through May 2027, which will accommodate the quantitative as well as the qualitative components of the study. The first phase is a quantitative prospective cohort study aimed at assessing the psychosocial risk level of pregnant women and its association perinatal outcomes, maternal and neonatal, among women attending health centers and private obstetrics and gynecology clinics in Tabriz, Iran. The qualitative phase will be conducted concurrently with the quantitative phase during the follow-up period. Finally, the results from phase 1 and phase 2 will be integrated in the discussion to achieve a deeper understanding of maternal and neonatal outcomes related to psychosocial risk factors (Fig. 1).

Fig. 1.

Study visual diagram

Phase I: quantitative study

Study type and participants

This phase is a prospective cohort study in which women will enter the study at 12–14 weeks of gestation. Based on the scores obtained from the psychosocial risk assessment, they will be assigned to either the exposed (high-risk) or unexposed (low-risk) group. Subsequently, all participants in both groups will be followed prospectively until 6 weeks following delivery.

Inclusion criteria

1. Pregnant women at 12–14 weeks of gestation

2. Nulliparous and multiparous pregnant women with any history of type of delivery

3. Ability to read and write (at least a fifth-grade primary education)

Exclusion criteria

1. Multiple pregnancy (e.g., twins or triplets)

2. Abortion/Miscarriage

3. Medical conditions including: Anemia (Hemoglobin below 10 mg/dL), Rheumatoid Arthritis (active disease with clinical symptoms such as joint pain and swelling, confirmed by an internist), Cardiac Diseases (heart failure, cardiomyopathy, functional impairment Class II or higher according to the NYHA 2020 classification), Uncontrolled Asthma, Thyroid Disorders (uncontrolled hyperthyroidism or hypothyroidism, confirmed by an internist), Recent Seizures (at least one seizure episode within the last 6 months), Other Neurological Disorders: Multiple Sclerosis (MS: relapse during pregnancy or requiring corticosteroid therapy), Chronic Migraine (at least 15 days of headache per month) with neurological symptoms (aura), Severe Gestational Diabetes and Overt Diabetes (with signs of vascular involvement or nephropathy)

   Note: All aforementioned conditions require confirmation and diagnosis by an internist or an obstetrician.

4. History of high-risk pregnancies (various types of hypertensions, preterm labor, etc.)

Research sample

In this research stage, the sample will comprise pregnant women visiting urban and peri-urban health centers, the midwifery clinics of Al-Zahra and 29-Bahman, and three private obstetrics clinics across three socioeconomic regions (low, middle, and high) in Tabriz. These women are attending these centers at 12–14 weeks of gestation for routine prenatal care and monitoring.

Research environment

The research will be conducted in women’s clinics within both teaching and non-teaching hospitals affiliated with Tabriz University of Medical Sciences, private obstetrics and gynecology clinics, and urban and peri-urban health centers across Tabriz.

Sample size

Sample size calculations were derived from the findings of Schmied et al. [75]. As no studies were identified for the primary outcome variables of pregnancy experience and childbirth experience, the calculations were performed using depression prevalence rates in the high- and low-psychosocial risk groups (based on the ANRQ instrument). Considering P1 = 21% (depression prevalence in the high-risk group) and P2 = 4% (depression prevalence in the low-risk group), along with α = 0.05 and 80% power, the required sample was calculated as 118 participants per group. After accounting for a 10% attrition rate, the sample size increased to 130 individuals. Furthermore, given the cluster sampling approach, the sample size was multiplied by a design effect of 2, yielding a final sample size of 260 women.

Sampling method

Following receipt of ethical approval, sampling will commence among pregnant women at 12–14 weeks of gestation. A cluster sampling approach will be adopted; initially, 25% of the centers will be chosen at random via www.random.org. Within each selected center, eligible participants will be recruited through simple random sampling (also using www.random.org), proportionate to the number of pregnant women at 12–14 weeks of gestation covered by that facility. To facilitate this, a roster of potential participants along with their contact numbers will be obtained from the SIB system (Integrated Health System). During telephone screening, selected individuals will be assessed against the inclusion and exclusion criteria. Those who meet the criteria and express willingness to take part will receive a thorough explanation of the research aims and procedures, and an in-person meeting will be arranged. At the face-to-face session, written informed consent will be secured, and the psychosocial risk assessment, along with the socio-demographic and reproductive characteristics questionnaires, will be completed.

Data collection tools

Quantitative data will be gathered using a battery of validated instruments, including a Sociodemographic and Obstetric Characteristics form, a Maternal and Neonatal Outcomes Checklist, the Antenatal Risk Questionnaire‑Revised (ANRQ‑R), the Pregnancy Experience Scale (PES), the Childbirth Experience Questionnaire version 2.0 (CEQ‑2), the Edinburgh Postnatal Depression Scale (EPDS), the Postpartum Specific Anxiety Scale Research Short‑Form (PSAS‑RSF), the Wijma Delivery Expectancy Questionnaire version A (W‑DEQ‑A), the Barkin Index of Maternal Functioning (BIMF), and a measure of Breastfeeding Self‑Efficacy.

Sociodemographic and reproductive characteristics form

A sociodemographic and reproductive characteristics form will be completed to gather data on maternal age, age at first marriage, marital status, housing type, self-reported sufficiency of monthly household income, educational level of both the mother and her spouse, employment status of both partners, substance use (including tobacco, alcohol, and illicit drugs) prior to and during gestation, gravidity and parity, infertility history, unintended pregnancy, undesired fetal sex, and number of living children.

Maternal and neonatal outcomes form

This form encompasses items pertaining to gestational age at birth, pregnancy-related complications (including gestational hypertension, preeclampsia, postpartum vaginal bleeding, intrauterine fetal death, and neonatal mortality), mode of delivery, labour duration, history of complicated deliveries, maternal hospital readmission due to postpartum complications, neonatal sex, birth weight, length and head circumference at birth, and neonatal admission to the Neonatal Intensive Care Unit (NICU).

Antenatal Risk Questionnaire-Revised (ANRQ-R)

The ANRQ-R, introduced by Marie-Paule Austin in 2021 as a revision of the original ANRQ [5]. incorporates several key modifications. These include reducing mental health history items from three to two, consolidating recent stressors into a single scored item based on distress severity rather than event counting, merging childhood maltreatment items into one, and adding two new items for intimate partner violence and substance misuse. The instrument consists of eleven scored items (four binary, seven Likert-scaled), each contributing up to five points for a total score ranging from 5 to 55—higher scores indicating greater psychosocial risk. These items assess ten psychosocial domains, including mental health history, partner relationship quality, social support, recent stressors, worry/perfectionism, adverse childhood experiences, maternal relationship quality, partner violence, and substance use. Likert responses are classified as low (1–3) or high (4+). Non-scored items collect additional clinical information such as help-seeking history and recent stressor details. Structural and linguistic refinements were made following pilot testing to improve clarity, while core items were retained. Psychometric evaluation among 1,670 women demonstrated moderate to good reliability, with an overall ICC of 0.77 and individual item ICCs ranging from 0.65 to 0.80. While the ANRQ‑R has demonstrated acceptable validity and reliability in Australian [76], Turkish [77], and Bulgarian [78] samples, the present study will conduct the first psychometric evaluation of this instrument within an Iranian population.

Pregnancy Experience Scale (PES)

The short-form Pregnancy Experience Scale (PES), developed by DiPietro (2004), will be utilized to assess pregnancy-related hassles and uplifts. This 20-item measure comprises two 10-item subscales evaluating worry (hassles) and joy (uplifts) on a 4-point Likert scale ranging from 0 (never) to 3 (very high), with higher scores indicating greater perceived intensity in each domain [79]. The Persian translation of this instrument has previously demonstrated acceptable psychometric properties in Iranian populations (Cronbach’s α = 0.714; ICC = 0.721) [13].

Childbirth experience questionnaire version 2

The Persian translation of the Childbirth Experience Questionnaire version 2 (CEQ-2) will be employed to evaluate women’s childbirth experiences [80, 81]. This 25-item instrument encompasses four domains: personal capacity, professional support, perceived safety, and participation. Responses are recorded on a 4-point Likert scale for 22 items and a visual analogue scale (converted to 1–4 scores) for the remaining three items, with negatively worded items reverse-scored. Higher mean scores indicate more favorable childbirth experiences [80]. The Persian version has demonstrated excellent reliability in Iranian populations (Cronbach’s α = 0.93; ICC = 0.97) [81].

Edinburgh Postpartum Depression Scale (EPDS)

The Edinburgh Postnatal Depression Scale (EPDS), developed by Cox and colleagues (1987), will be administered to assess depressive symptoms during both pregnancy and the postpartum period. This 10-item self-report measure utilizes four response options per item, scored from 0 to 3, with total scores ranging from 0 to 30—higher scores denoting more severe depression. The original scale demonstrated concurrent validity of 0.78 against the Beck Depression Inventory and reliability of 0.75 (Cronbach’s alpha and split-half methods) [82]. The Persian translation has shown acceptable psychometric properties in Iranian populations, with concurrent validity ranging from 0.78 to 0.80 and Cronbach’s alpha coefficients between 0.75 and 0.86 [83].

Wijma Delivery Experience Questionnaire Version A (W-DEQ-A)

The Persian version of the Wijma Delivery Expectancy Questionnaire Version A (W-DEQ-A) will be employed to assess fear of childbirth. This 33-item instrument utilizes a 6-point Likert scale (0 = never to 5 = most times), with total scores ranging from 0 to 165—higher scores reflecting greater fear. Scores are categorized as follows: ≤37 (low), 38–65 (moderate), 66–85 (high), and > 85 (severe), with several items reverse-scored. The original scale demonstrated good reliability (Cronbach’s α = 0.89–0.92) [84], while the Persian version has shown excellent internal consistency (Cronbach’s α = 0.91) [85].

Postpartum specific anxiety scale research short-form

The Persian version of the Postpartum Specific Anxiety Scale Research Short-Form (PSAS-RSF), derived by Davies et al. from the original 51-item PSAS, will be utilized to assess postpartum-specific anxiety. This 16-item instrument evaluates the frequency (rather than severity) of anxiety symptoms in mothers of infants up to 12 months old across four domains (four items each): adjustment to the maternal role, practical infant care concerns, worries about maternal competence and attachment, and infant safety/well-being anxieties. Items are rated on a 4-point scale (1 = never to 4 = almost always), with total scores ranging from 16 to 64. The original scale demonstrated good overall reliability (McDonald’s ω = 0.88) [86], while the Persian version has shown acceptable reliability (Cronbach’s α = 0.72; ICC = 0.97) [87].

Breastfeeding performance

Breastfeeding performance will be evaluated 4–6 weeks postpartum using the Persian version of the questionnaire developed by Agunbiade (2012). This 6-item instrument assesses adherence to national breastfeeding guidelines; each response that aligns with guidelines receives one point. Total scores range from 0 to 6, with a score of 4 or higher indicating “good breastfeeding practice.” [88]. Asgarian et al. (2019) reported adequate reliability for the Persian version in Iran (Cronbach’s α = 0.92; inter-item correlations: 0.21–0.72; corrected item-total correlations: 0.44–0.75) [89].

Barkin Index of Maternal Functioning (BIMF)

The Persian version of the Barkin Index of Maternal Functioning (BIMF), developed by Barkin et al. (2010), will be utilized to assess maternal functioning. This 20-item self-report measure evaluates functioning across seven domains using a 7-point Likert scale (0–6). Following reverse-scoring of two items, total scores range from 0 to 120, with higher scores reflecting better functioning [90]. Following validation in an Iranian population by Mirghafourvand and associates, the Persian adaptation of this instrument was reduced to 17 items (three items having been eliminated) and exhibited satisfactory internal consistency, with a Cronbach’s alpha coefficient of 0.81 [91].

Validity and reliability of the ANRQ-R

All instruments utilized in this study, except for the ANRQ‑R, have been previously validated in Iranian populations. For the ANRQ‑R, psychometric properties will be established through translation, content validity, face validity, and construct validity procedures. The translation process will follow a forward‑backward approach. Initially, the original English version will be translated into Persian by two bilingual translators, with emphasis on semantic equivalence. The translations will be merged, reviewed by an expert panel, and then back‑translated into English by translator’s blind to the original version, prioritizing semantic, terminological, experiential, and perceptual equivalence. The back‑translated version will be reviewed by a panel of bilingual experts [92]. Content validity will be assessed both qualitatively (expert feedback on clarity, relevance, and item placement) and quantitatively using the Content Validity Ratio (CVR) and Content Validity Index (CVI). Face validity will also be evaluated through qualitative interviews with ten pregnant women and quantitatively via the item impact method, with scores above 1.5 considered acceptable. Construct validity will be examined through exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). EFA will utilize principal axis factoring with direct oblimin rotation. Model adequacy will be assessed using the Kaiser‑Meyer‑Olkin (KMO) measure and Bartlett’s test of sphericity, with factor loadings of 0.3 or above retained. The number of factors will be determined based on variance explained and scree plot evaluation. CFA will then be performed to confirm the factor structure, with acceptable model fit defined as RMSEA < 0.08, SRMR < 0.08, CFI ≥ 0.90, TLI ≥ 0.95, and χ²/df < 5.0 [93]. Reliability will be assessed through test‑retest analysis (ICC) and internal consistency (Cronbach’s α).

Analysis approach

Statistical analyses will be performed using SPSS version 26. Descriptive methods will summarize sociodemographic and obstetric data: categorical variables as frequencies and percentages; continuous variables as mean ± standard deviation (normal distribution) or median with interquartile range (non‑normal distribution). To examine associations between psychosocial risk levels and outcome variables (pregnancy experience, childbirth experience, postpartum depression, postpartum anxiety, fear of childbirth, and breastfeeding performance), bivariate comparisons will be conducted using independent t‑tests, followed by a General Linear Model (GLM) for multivariate analysis adjusting for confounders including parity and previous delivery mode. For categorical outcomes (exclusive breastfeeding, mode of delivery, preterm birth, NICU admission, and hypertensive disorders), bivariate analysis will employ the Chi‑square or Fisher’s exact test, with multivariate logistic regression subsequently applied to control for confounding factors. A two‑sided P‑value < 0.05 will be considered statistically significant.

Phase II/qualitative study

Study type and participants

The qualitative strand of this investigation will utilize a conventional content analysis method. Eligible individuals for this phase will be recruited from two separate cohorts: women with high psychosocial risk (ANRQ‑R total score ≥ 23) and those with low psychosocial risk (ANRQ‑R score < 23).

Sampling

Participants for the qualitative phase will be recruited through purposive sampling, specifically selecting individuals from both high- and low-risk psychosocial groups who are both willing and capable of expressing their experiences in depth. Sampling will follow an iterative process and will be continued until saturation is reached—operationally defined as the stage where interviews yield no new information or additional codes [93].

Research environment

The selection of interview locations will be guided by two principles: adherence to qualitative research standards, which emphasize natural and authentic environments, and respect for participant preferences. Thus, each interview will be conducted in a setting where suitable conditions exist and which the participant finds comfortable and convenient.

Data collection process

Data generation for the qualitative strand will be carried out through in‑depth, semi‑structured interviews, guided by a pre‑designed protocol featuring open‑ended questions aligned with the study’s aims. The first author (SR), a PhD candidate in midwifery with ten years of practical experience in intrapartum and postpartum care, will conduct all interviews personally. Participants will be invited to openly share their views and lived experiences concerning the topics covered in the interview guide. Notably, the qualitative questions will be developed alongside the quantitative phase findings. Each interview will commence with a central question: “What are the perceptions of the pregnancy experience among mothers with high and low levels of psychosocial risk?” This will be followed by probing questions, including: “Please describe your pregnancy and what you learned from it. What factors contributed to your sense of peace and security during pregnancy? What factors caused discomfort, dissatisfaction, or worry? Whose support was helpful to you, and in what ways?” To ensure comprehensive exploration, the interviewer will use additional prompts derived from participants’ responses, such as: “Could you tell me more about that? Why do you think that is? Can you give me an example to help me understand?” Throughout each session, the researcher will take detailed notes on a structured form, documenting non‑verbal cues including facial expressions, tone of voice, and body language, along with the exact time and location of each interview.

Data analysis

The analytical framework for this phase will be based on the conventional method of qualitative content analysis. This approach begins with repeated and careful readings of the complete text in order to gain a holistic understanding of its content. Following this, the researcher will perform a meticulous, word-by-word review of the transcripts to extract meaningful codes, during which keywords that represent core concepts will be pinpointed. As the analysis progresses, the researcher will systematically record insights derived from the initial readings, continuing this documentation process until a stable basis for code emergence is achieved. At this juncture, code labels that synthesize multiple fundamental ideas will be identified and derived. Subsequently, the codes will be sorted according to their similarities or differences. Prior application of this approach indicates that roughly 10 to 15 categories typically suffice to meaningfully group a large volume of codes. These categories will subsequently serve to arrange and structure the codes into logical clusters. The present investigation will specifically employ conventional content analysis, an approach that extends beyond the manifest, literal content of interview transcripts to also reveal underlying meanings and more abstract themes contained within the data. It should also be noted that MAXQDA software, version 12, will be employed to efficiently manage both the interview texts and the resulting codes throughout the analysis process.

Trustworthiness of qualitative data

To assess the rigor of the qualitative analysis, four established criteria, dependability, credibility, transferability and confirmability, will be employed [94]. The researcher will strengthen the study’s validity by engaging in an extended period of data collection and analysis. A professional yet trust-based rapport will be established with participants through critical review of the interviews. Furthermore, the research team will synthesize feedback from both participants (via member checking) and fellow team members, while ensuring maximum variation in socio-economic backgrounds to bolster the findings’ robustness. Regarding dependability, the research team, together with external auditors, will engage in an iterative process of developing, piloting, and refining the interview protocols and coding schemes. This systematic approach is intended to enable a thorough investigation of the maternal and neonatal outcomes linked to psychosocial risk factors. To confirm confirmability and to give priority to the participants’ authentic perspectives over any potential researcher bias, two independent experts in qualitative methodology will audit the coding process and the thematic interpretations derived from the data. Finally, to support transferability, purposive sampling will be used to recruit participants with diverse demographic characteristics, including varying age groups, educational levels, and socio-economic statuses. This strategy will facilitate the application of the results to comparable clinical and social contexts.

Phase III: mixed phase

Integration of findings from the qualitative and quantitative strands will occur within the discussion section. Quantitative data pertaining to psychosocial risk levels and their associations with maternal and neonatal outcomes will be presented first, followed by qualitative findings illustrated through participant quotations addressing similar themes. An interpretive synthesis will then be offered to elucidate how the qualitative accounts corroborate, contradict, or expand upon the quantitative results.

Discussion

Women in LMICs bear a disproportionate burden of psychosocial risk exposures during pregnancy. These encompass current stressors, suboptimal partner relationships, inadequate social support, trauma history, current or prior depression and anxiety [9], substance and alcohol abuse [10], low socioeconomic status, childhood maltreatment, and intimate partner violence [11]. Although prenatal services predominantly target physical well-being, the psychological and emotional dimensions of maternal health are frequently neglected—constituting a significant gap in healthcare delivery. This issue is evident not only in countries like Iran [70] but also in several high-income nations [62, 69]. Although numerous studies have investigated variables such as violence, anxiety, depression, and social support, they have predominantly examined these factors in isolation, failing to account for the cumulative and multidimensional nature of psychosocial risks [75, 95, 96]. Furthermore, many studies utilize cross-sectional designs in Iran, which limits the ability to establish causal relationships between psychological exposures and pregnancy outcomes [95, 96]. Even in longitudinal studies, psychological factors are often assessed at a single time point, neglecting potential fluctuations throughout the course of pregnancy [73, 97]. Another significant gap is the unbalanced focus on outcomes; some research focuses exclusively on neonatal outcomes, such as low birth weight [98, 99], while maternal outcomes are neglected—or vice versa [78, 100]. However, maternal and neonatal health are inextricably linked, and examining them simultaneously provides a more comprehensive understanding of the impact of psychological factors.

While midwives are on the front lines of providing initial prenatal visits in health centers, they often possess limited specialized knowledge and experience in screening and diagnosing various maternal mental disorders. Therefore, there is an urgent need for a tool that can rapidly predict high-risk individuals with a high odds ratio, facilitating early identification, referral, and prompt treatment [101]. The ANRQ-R was designed to be a shorter, more user-friendly version that can be integrated into routine use in busy clinical settings, such as midwifery clinics. Consequently, brevity and clinical utility were the two primary objectives in its development. Beyond being evidence-based, concise, and practical, this tool is reliable and valid. By providing a multidimensional profile of the pregnant mother’s psychosocial status, it enables early identification of risk factors, thereby guiding midwifery and healthcare personnel toward the most appropriate care pathways [76].

Conclusion

By adopting a mixed-methods approach, this research utilizes a comprehensive tool—the ANRQ-R—to conduct a multidimensional assessment of psychosocial risks and examine their associations with a full spectrum of maternal and neonatal outcomes. Furthermore, by elucidating the lived experiences of both high-risk and low-risk pregnant women, this study provides a profound understanding of the underlying psychosocial dynamics. Such an integrated approach not only facilitates the early identification of vulnerable women but also establishes a robust foundation for designing targeted interventions, optimizing prenatal screening programs, and ultimately enhancing maternal and infant health. Consequently, both theoretically and practically, the present study represents a crucial step toward strengthening the evidence base in the field of perinatal mental health.

Authors’ contributions

MM, MS, FA and SR contributed to the design of the protocol. MM and SR contributed to the implementation and analysis plan. MM and SR has written the first draft of this protocol article and all authors have critically read the text and contributed with inputs and revisions, and all authors read and approved the final manuscript. MM is the guarantor.

Funding

Tabriz University of Medical Sciences provided funding, but it had no role in the design and conduct of the study and decision to this manuscript writing and submission (Grant number: 78729).

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

This protocol adheres to the principles outlined in the Declaration of Helsinki. Ethical clearance has been obtained from the institutional review board of Tabriz University of Medical Sciences (IR.TBZMED.REC.1405.106). All participants will provide written informed consent prior to enrollment, and confidentiality of their data will be strictly maintained. Participants will be explicitly informed of their right to withdraw from the study at any time without consequences.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.