Womenʼs attitude towards COVID‐19 vaccination in pregnancy: A survey study in northern Italy

Abstract

Objective

To investigate attitudes and risk perceptions towards the coronavirus disease 2019 (COVID‐19) vaccine and reasons for hesitancy among pregnant women.

Methods

A prospective survey study was conducted at a University Maternity Department. Participants included any pregnant woman aged 18 years or older, able to understand the Italian language, who accessed the antenatal clinic for a prenatal appointment. The survey comprised questions about sociodemographic characteristics, pregnancy vaccination history, and perception of risk related to the immunization for the woman herself and her infant.

Results

A total of 538 women completed the questionnaire, 445 (82.7%) accepted COVID‐19 vaccination. Women vaccinated against pertussis were three times more likely to take up the COVID‐19 vaccine (odds ratio [OR] 3.19; 95% confidence interval [CI] 1.78–5.72). Having had COVID‐19 during pregnancy (OR 0.24; 95% CI 0.11–0.54), and having a high‐risk perception towards the immunization for the fetus (OR 0.18; 95% CI 0.09–0.34) were factors associated with vaccine hesitancy. Lack of safety data in pregnancy and the possibility of harm to the fetus were the main concerns.

Conclusion

A trusting and supportive relationship with the healthcare professional to address fears, and the transmission of evidence‐based information, are pivotal to guide women through an informed choice. Understanding the determinants implicated in women's decision making might guide towards effective public health strategies to boost vaccine acceptance.

Synopsis

Acceptance rate of COVID‐19 vaccination was high, but participants expressed concerns regarding the safety of COVID‐19 vaccine in pregnancy and of their unborn child.

1. INTRODUCTION

Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection in pregnancy is associated with increased risks of poor maternal and perinatal outcomes. ¹ , ² , ³ , ⁴ For this reason, pregnant women are to be considered a vulnerable population and, in turn, a priority group for coronavirus disease 2019 (COVID‐19) vaccination. ⁵

The obstetrical population was initially excluded from the vaccine trials. However, increasing data have now demonstrated both the safety ⁶ , ⁷ and effectiveness for preventing severe disease ⁸ of COVID‐19 vaccination in pregnancy, leading to its worldwide recommendation. ⁹ , ¹⁰ , ¹¹ Notwithstanding this, vaccination coverage among the obstetrical population has been alarmingly low. ⁴ , ¹²

The Italian National Institute of Health has recommended the vaccination for pregnant and lactating women since September 2021. ¹³ However, the Lombardy Region Health Authority anticipated the national suggestion by 2 months with the release of a Practice Advisory. ¹⁴ This intervention was driven by the fact that Lombardy region was the global epicenter of SARS‐CoV‐2 infection as it saw the first major outbreak in Europe in March 2020.

Considering that Italy was one of the hardest hit European countries in the early stages of the pandemic, ¹⁵ and that SARS‐CoV‐2 immunization can prevent the severe form of COVID‐19 and, in turn, the related perinatal adverse events, ⁸ it is crucial to understand vaccination intentions among the Italian obstetric population. So far, since the Ministry of Health gave priority to the women in pregnancy to be vaccinated against COVID‐19, no studies have been conducted in Italy aiming to assess pregnant women's attitude towards the new vaccine.

The aim of this study was to investigate attitudes and risk perceptions towards the COVID‐19 vaccine and reasons for hesitancy among pregnant women in northern Italy.

Given that the COVID‐19 pandemic is still ongoing and reported rates of vaccination in pregnancy have been consistently low, such information could provide valuable knowledge to draft targeted interventions and health strategies for promoting vaccine uptake in pregnancy.

2. MATERIALS AND METHODS

This was a prospective survey study conducted between February 1, 2022 and March 3, 2022 at a University Maternity Department in northern Italy, with approximately 2600 births per annum.

The survey was given to any pregnant woman who accessed the prenatal clinic for her prenatal appointment at any gestational age.

Women were considered eligible for participation if they were 18 years or older and were able to understand the Italian language.

Data were collected using a self‐administered questionnaire developed based on a literature review on the topic. The survey comprised questions about sociodemographic characteristics, indications of a high‐ or low‐risk pregnancy, vaccination history, COVID‐19 vaccination uptake, reasons for choosing to receive or not the COVID‐19 vaccine, whether the woman received information regarding the COVID‐19 vaccine and from whom, and perception of risk related to the COVID‐19 vaccination for herself and her infant. High‐risk pregnancies included any previous medical history, any maternal of fetal complications, and placental anomalies.

Questions such as: “Did you receive/will you receive the whooping cough vaccine during this pregnancy?”, allowed for a “yes” or “no” answer. Questions regarding the COVID‐19 vaccine allowed for a “yes” or “no” answer followed by different options of reasons to receive, or not, the vaccine and a dedicated space with the opportunity to explain the choice if the motivation was not listed. Information related to the risk perception for the expecting mother and her infant to receive the COVID‐19 vaccine were collected using a five‐point Likert Scale, where 1 was equal to “null risk” and 5 to “very high risk”.

A sample size of 384 women was determined to be sufficient to produce a confidence interval (CI) of 95% with a 5% error margin. The target population size was based on the number of live births in 2020 as reported by the Italian National Institute of Statistics ¹⁶ ; the expected frequency (outcome probability) was assumed to be 37% based on previous literature that had reported vaccine acceptance among pregnant women ranging between 37% and 77%. ⁴ , ¹⁷ , ¹⁸ By assuming that 10% of eligible women would not consent to participate or would return an incomplete survey, the minimum sample size needed was calculated to be 423 participants. The Sample Size Calculator developed by the Creative Research Systems was used for the calculation.

Continuous characteristics were described as median or mean and standard deviation, as appropriate, and qualitative variables were reported as count or frequency. The impact of variables potentially associated with the decision to receive or not the COVID‐19 vaccine was first assessed by univariate analysis and reported as odds ratio (OR) with 95% CI. A logistic regression model was applied to relate the COVID‐19 vaccine uptake choice with the factors observed as significant from the univariate model, thus adjusting for potential confounders. Variables related to the risk perception questions were described as continuous and categorical. The variable was considered categorical with the risk perception coded as Low when the answer was 1 or 2, as Medium when the answer was 3, and as High when the answer was 4 or 5.

Statistical analyses were performed using STATA/MP 15.0 (StataCorp) and the open‐source R software v.3.6.0 (R Foundation for Statistical Computing).

This study was approved by the Brianza Ethics Committee (N.2988/January 17, 2022).

3. RESULTS

A total of 586 participants completed the survey; 48 (8.2%) responses were excluded because women had already been vaccinated before the pregnancy (n = 33) or surveys contained invalid responses (n = 15), thus leading to a final study population of 538 women.

Mean maternal age was 33.2 years (±4.6 standard deviation) and the median pregnancy duration at the questionnaire compilation date was 29⁺² weeks (range 6⁺³–41⁺⁴ weeks). All women stated their intent to receive, or not, the COVID‐19 vaccine, with 445 (82.7%) women reporting to have accepted COVID‐19 vaccination and 93 (17.3%) to have declined it.

Sociodemographic features and women's answers to the questionnaire are reported in Table 1. Women who were unemployed (P = 0.027), who did not accept the diphtheria, tetanus, pertussis (TDaP) (P < 0.001) and influenza (P < 0.001) vaccines, who had COVID‐19 before or during pregnancy (P < 0.001), who reported a lack of information regarding the COVID‐19 vaccine (P < 0.001), and who had a high‐risk perception towards the immunization for themselves or the infant, were more likely to be not vaccinated against COVID‐19.

TABLE 1.

Women's answers based on COVID‐19 vaccine uptake ^a

Question	Answer	Overall	Vaccinated (N = 445; 82.7%)	Not vaccinated (N = 93; 17.3%)	Univariate analysis
					OR (95% CI)	P value
Single	Yes	8 (1.5)	5 (62.5)	3 (37.5)	0.34 (0.08–1.47)	0.149
	No	526 (98.5)	436 (82.9)	90 (17.1)
Employed	Yes	478 (89.4)	401 (83.9)	77 (16.1)	2.03 (1.09–3.80)	0.027
	No	57 (10.7)	41 (71.9)	16 (28.1)
Education	Primary school	39 (7.3)	31 (79.5)	8 (20.5)	0.75 (0.53–1.05)	0.094
	Secondary school	204 (38.1)	162 (79.4)	42 (20.6)
	University	292 (54.6)	249 (85.3)	43 (14.7)
Nulliparity	Yes	284 (52.9)	236 (83.1)	48 (16.9)	1.06 (0.68–1.66)	0.787
	No	253 (47.1)	208 (82.2)	45 (17.8)
Low‐risk pregnancy	Yes	349 (67.2)	285 (81.7)	64 (18.3)	0.70 (0.42–1.17)	0.170
	No	170 (32.8)	147 (86.5)	23 (13.5)
Have you ever been vaccinated in your life?	Yes	533 (99.3)	441 (82.7)	92 (17.3)	1.60 (0.16–15.5)	0.686
	No	4 (0.7)	3 (75.0)	1 (25.0)
Have you been vaccinated for influenza in the present pregnancy?	Yes	209 (39.0)	191 (91.4)	18 (8.6)	3.09 (1.79–5.35)	0.000
	No	328 (61.1)	254 (77.4)	74 (22.6)
Have you been vaccinated for whooping cough in the present pregnancy?	Yes	349 (65.7)	314 (90.0)	35 (10.0)	3.99 (2.49–6.38)	0.000
	No	182 (34.3)	126 (69.2)	56 (30.8)
Did you have COVID‐19?	Yes	202 (37.5)	152 (75.3)	50 (24.8)	0.45 (0.28–0.70)	0.000
	No	336 (62.5)	293 (87.2)	43 (12.8)
Did you have COVID‐19 in this pregnancy?	Yes	123 (22.9)	88 (71.5)	35 (28.5)	0.41 (0.25–0.66)	0.000
	No	415 (77.1)	357 (86.0)	58 (14.0)
Do you think that you had enough information about the COVID‐19 vaccine in pregnancy?	Yes	395 (75.8)	337 (85.3)	58 (14.7)	2.23 (1.38–3.61)	0.001
	No	126 (24.2)	91 (72.2)	35 (27.8)
What is the risk perception related to the COVID‐19 vaccination for yourself?	Low	284 (52.8)	268 (94.4)	16 (5.6)	0.20 (0.14–0.29)	0.000
	Medium	194 (36.1)	153 (78.9)	41 (21.1)
	High	60 (11.2)	24 (40.0)	36 (60.0)
What is the risk perception related to the COVID‐19 vaccination for your baby?	Low	273 (50.7)	263 (96.3)	10 (3.7)	0.17 (0.12–0.25)	0.000
	Medium	186 (34.6)	148 (79.6)	38 (20.4)
	High	79 (14.7)	34 (43.0)	45 (57.0)

Abbreviations: CI, confidence interval; COVID‐19, coronavirus disease 2019; OR, odds ratio.

^a Data are presented as number (percentage) unless otherwise stated.

The logistic regression analysis adjusted for potential confounders identified that women vaccinated against TDaP were three times more likely to also receive the COVID‐19 vaccine (OR 3.19; 95% CI 1.78–5.72). Conversely, having had COVID‐19 in the index pregnancy (OR 0.24; 95% CI 0.11–0.54) and having a high risk perception towards the immunization for the fetus (OR 0.18; 95% CI 0.09–0.34) were factors independently associated with vaccine uptake hesitancy; such women were over 70% and 80% less likely to be vaccinated against COVID‐19, respectively.

A summary of reasons for refusing the COVID‐19 vaccines is given in Figure 1, showing women's concerns mostly related to the lack of data on the immunization safety in the pregnant population (N = 54; 58.1%) and the possibility of harm to the fetus (N = 29; 31.2%).

FIGURE 1.

Women's reasons for not taking up the COVID‐19 vaccine.

The most frequent maternal source of information regarding COVID‐19 vaccine was the healthcare professional providing prenatal care (N = 337; 85.3%), followed by the Ministry of Health's website (N = 189; 47.8%) (Figure 2).

FIGURE 2.

Maternal source of information regarding COVID‐19 vaccine.

The distribution of maternal risk perception of the immunization reported by the entire sample compared with the risk perception for the mother herself or for her infant, based on COVID‐19 vaccine uptake, is shown in Figure 3.

FIGURE 3.

Distribution of maternal risk perception of the immunization reported by the entire sample compared with the risk perception for the mother herself (Panel a) or for her infant (Panel b), based on COVID‐19 vaccine uptake. The risk perception score on the Likert scale included in the questionnaire ranged from 1 to 5. The blue bars (Panel a) and the orange bars (Panel b) show the score of risk perception of the immunization (1, 2, 3, 4, or 5) reported by the entire sample on the Likert scale for the women themselves and for their infant, respectively. The scores stated by the entire sample are compared with the risk perception indicated by vaccinated and unvaccinated participants for themselves (Panel a) and for their infant (Panel b).

There were no differences in maternal risk perception trends either for the mother herself or for her infant between women who were vaccinated and those who were not. However, we observed that low perception of risks was more common among women who accepted immunization compared with those who did not. Among vaccinated women, only 1 (0.2%) scored the perception of both risks as 5 on the Likert scale. Conversely, women who were not vaccinated against COVID‐19 were more likely to report a higher perception of risks. In fact, 13 (14%) and 21 (22.6%) participants reported a risk perception equal to 5 for themselves and for their infant, respectively.

4. DISCUSSION

The aim of this study was to understand pregnant women's attitudes towards the new vaccine against COVID‐19, after the strong recommendation made by the Italian Ministry of Health to accept immunization during pregnancy.

We recorded an acceptance rate of 82.7%, which was much higher than that observed in previous similar studies among pregnant women. ⁴ , ¹⁷ , ¹⁸ This is probably a result of the strong dissemination of professional and reliable information regarding the safety and efficacy of COVID‐19 vaccine implemented at our institution. Information leaflets and counseling were adopted to support women make an informed choice, which probably helped them to feel confident and knowledgeable, experiencing fewer decisional conflicts and less anxiety. ¹⁹ In addition, our findings support the hypothesis that vaccine uptake and hesitancy rates are context‐specific, ²⁰ hence vaccination campaigns should be based on data gathered in a definite setting as they might be difficult to generalize.

Although the COVID‐19 vaccination coverage was higher than expected, our findings regarding reasons to decline the vaccine mirror the existing evidence.

We found that more than half of the women in the non‐vaccinated group were mainly worried about the lack of safety data of the immunization in pregnancy. ¹⁸ , ²¹ At the beginning of the pandemic, pregnant women were not included in any clinical trials. ²² This initial inconsistency of available data might have built confusion among pregnant women, possibly leading to mistrust of the vaccine even in the presence of updated evidence. In an online anonymous survey across 16 countries and 5294 pregnant women, Skjefte et al. ²³ found that 44.9% of the sample declined immunization because they were worried that the vaccine's approval had been expedited for political reasons. Although this aspect was not specifically addressed in our questionnaire, the existing literature cites public concerns about the rapid vaccine development as a primary reason to decline it in high‐income countries. ²⁴ This could also underlie the high maternal risk perception for the fetus that we identified as independently associated with vaccine hesitancy ¹⁸ in our study population. Having concerns regarding vaccine safety is also one of the most important factors affecting women's decision making during pregnancy with other recommended vaccines. ²⁵ , ²⁶

We recognized having experienced the disease during pregnancy as another variable independently associated with vaccine refusal after adjusting for confounders. The mistaken opinion that having had COVID‐19 recently is a protection for future infections or a reason to avoid vaccination ²⁷ is a substantial issue that should be addressed by healthcare professionals and authorities, for the whole population and specifically for the obstetric one.

As has been widely reported, ²¹ , ²⁸ we found that women who had not been vaccinated against influenza and pertussis in pregnancy were three and four times more likely to also reject the COVID‐19 vaccine during pregnancy, respectively. Notwithstanding this, the vaccination coverage in pregnancy was 39% for the influenza vaccine and 65.7% for the pertussis vaccine. These rates are higher than those previously reported for Italy, ²⁹ and in line with rates of other European countries, such as England and Spain, where both immunizations are recommended. ³⁰ Other authors ³¹ have described that women saw influenza as a disease affecting the mother, whereas they view pertussis as a risk for the infant, and so more often consider vaccination against the latter. Given the high rate of COVID‐19 vaccine acceptance observed in our study, we could speculate that, perhaps, women in our sample have understood the potential risks of this disease for the fetus, thus they wanted to protect their child from severe complications. This awareness might be facilitated by non‐judgmental and open discussion with healthcare professionals, who should address women's questions and the doubts implicated in their decision to receive the vaccine. A trusting relationship with healthcare providers and their recommendation to receive the vaccine has been seen as substantial to support women's acceptance of maternal vaccination ²⁶ , ³² and, perhaps, it might have played a role also for our sample. Although receiving enough information regarding the vaccine was not significant in the multivariate model, our questionnaire showed that 85.3% of the sample received information from their healthcare professional providing care during pregnancy and for 22% of them, this was the single source of information. Hence, the role of professionals seems to be critical in making women feel supported and aware, and guiding them throughout an informed choice.

Our study evaluated the uptake rate of COVID‐19 vaccination in pregnant women and the reasons guiding their positive or negative decision. Information leaflets and counseling were offered to all women who accessed prenatal care. We believe the chance that women who decline the vaccine will change their mind is low. In line with this observation, we noted that only four women reported that they had not received any immunization in their life. This result suggests the need for different interventions for vaccine‐hesitant individuals. As proposed by other authors, motivational interviewing techniques might be adopted as an effective method to increase acceptance. ³³ Again, the role of the healthcare provider within this approach is pivotal, in order to establish a partnership model of care based on respectful and empathetic discussion. ³³

Limitations of the study include enrollment of pregnant women in a single center, which limits its generalizability to the national population. Participants, instead, represent a sample in an area where the COVID‐19 pandemic was critical and hard to manage, ³⁴ so they may be particularly inclined to be vaccinated. Conversely, it can also allow more consistent analysis of reasons for not accepting the COVID‐19 vaccine.

We did not find any correlation between COVID‐19 vaccine acceptance and sociodemographic features; however, we did not collect data on ethnic group, which was previously reported as a significant factor implicated in COVID‐19 vaccine uptake. ²⁸ , ³⁵ , ³⁶

The strength of the present study is that we explored, for the first time in Italy, the actual rate of being vaccinated during pregnancy among the women studied, following a strong recommendation made by the Italian Ministry of Health. By giving an actual perspective on women's views regarding COVID‐19 vaccination, our findings might be helpful in guiding public health strategies and research efforts towards messaging and actions to improve COVID‐19 vaccination acceptance among the Italian obstetric population.

Given that pregnant women are at increased risk of morbidity associated with COVID‐19, maternal vaccination against the disease in pregnancy is an essential component to controlling disease burden and to protect mothers and newborns from potentially severe infections.

Considering concerns expressed by participants regarding the safety of COVID‐19 vaccination in pregnancy for themselves and their unborn child, a trusting and supportive relationship with the healthcare professional to address anxieties and fears and the transmission of evidence‐based information, are pivotal to guide women through an informed choice.

Understanding the determinants implicated in the decision making process to accept or not the COVID‐19 vaccine is of global concern and might provide guidance towards effective public health messaging and strategies to boost vaccine acceptance.

AUTHOR CONTRIBUTIONS

Elisabetta Colciago contributed to design, planning, data collection, data analysis, data interpretation, manuscript writing, and critical revision of the manuscript; Giulia Capitoli contributed to data analysis, data interpretation, and critical revision of the manuscript; Patrizia Vergani contributed to design, data interpretation, and critical revision of the manuscript; and Sara Ornaghi contributed to supervision; design, data interpretation, and critical revision of the manuscript. All authors gave their final approval of the version to be published.

CONFLICT OF INTEREST

The authors report no conflicts of interest.

Supporting information

Appendix S1

Colciago E, Capitoli G, Vergani P, Ornaghi S. Women's attitude towards COVID‐19 vaccination in pregnancy: A survey study in northern Italy. Int J Gynecol Obstet. 2022;00:1‐8. doi: 10.1002/ijgo.14506

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author upon reasonable request.