Factors influencing refusing of flu vaccination among pregnant women in Italy: Healthcare workers’ role

Background Pregnant women are at increased risk of influenza complications. Influenza vaccine provides them a substantial protection. Objective The aim of this study was to investigate determinants associated with non‐adherence to influenza vaccine recommendations in pregnant women in Italy. Methods A cross‐sectional study has been carried out among pregnant women attending their follow‐up visit in some mother and child services in a Region of Italy from October 2016 to January 2017. The study protocol was approved by the local research Ethics. A self‐administered close‐ended questionnaire has been administered to the pregnant women. Differences in background, socio‐demographic characteristics, knowledge and attitudes towards flu vaccine were tested in vaccinated and unvaccinated women. Multivariate analysis was performed to control for confounding factors. Results Three hundred and sixty‐six women answered the survey (97% response rate) and 96.1% (348) declared of being unvaccinated against influenza during the 2016‐2017 influenza season. Frequent reasons for refusing vaccination were drugs objection and concerns about vaccines’ effects. According to the refusal attitude, influenza knowledge was low in the group. Moreover, analysis showed that low adherence to vaccination is associated to lacking promotion of vaccination to pregnant women carried out by healthcare workers (P < 0.005). Conclusions Healthcare workers have a key role in assisting women during the gestational period, so their active involvement in vaccination promotion is essential. It is necessary to improve health care workers’ knowledge about vaccine relevance in protecting pregnancy and their communication skills to properly inform pregnant women.


| BACKG ROU N D
Influenza illness has been associated with increased rates of miscarriage, stillbirths, neonatal deaths, preterm deliveries and reduced birth weight. 1,2 Moreover, pregnant women despite others are at increased risk of influenza complications, including hospitalization and admission to intensive care units. 3 Influenza vaccine is safe and provides substantial protection to pregnant women, unborn foetuses and infants up to 6 months following delivery. 4,5 In fact, since 2005, the World Health Organization (WHO) has recommended including immunization for pregnant women into national influenza vaccination programs, restating its recommendations in the 2012 position paper. 6 In Italy, vaccination is offered for free to all women who, at the beginning of the epidemic season, are in the second or third trimester of gestation. 7 Despite its clinical importance and the health policies, influenza vaccination coverage in pregnant women is low in Europe (23.7%), 8 especially in Italy (2%). [9][10][11] Wider acceptance of maternal immunization has been hampered by the perception that limited data about safety are available. 12 The aim of this study was to investigate determinants associated with non-adherence to influenza vaccine in pregnant women.

| ME THODS
A cross-sectional study has been conducted over a 4-month period from October 2016 to January 2017, covering the typical epidemic influenza period in Italy. The Study was conducted during flu vaccination campaign, and vaccine was made available to expectant mothers in all involved health services during period.
This survey was carried out by means of a self-administered close-ended questionnaire which was distributed by trained medical staff in outpatient of obstetrics and gynaecology departments.
Services that accepted to participate to the investigation were five local obstetrics and gynaecology counselling facility and the two biggest hospitals in the Marches, a central Italy Region.
The study was conducted according to the Declaration of Helsinki and current legislation and approved by the local research ethics committee of Marches Region.
In selected gynaecology and obstetric units, a resident or a nurse have informed potential participants about the survey while they were waiting for their medical appointment. After the informative moment, questionnaire was distributed to collaborative pregnant women who signed informed consent.
The minimum sample size necessary for this study was 280 women, calculated with the formula z 2 pq/d 2 assuming that p (non vaccination rate) = 76% (prevalence was taken from available scientific literature 8,[13][14][15] ), for confidence level of 95% and an error rate of 5%.
A convenience sampling method was used to recruit participants.
Eligibility criteria for participation were as follows: age between 18 and 45 years old, English or Italian language, current (first-third trimester)/planned pregnancy at the time of the study. The questionnaire included several items divided into three sections. The first section included socio-demographic characteristics (age, nationality, educational level, marital status, occupation) and background information about the potential to influenza exposure in the occupational settings (such as being occupied in regular duties, temporary change of duties, evaluation of potential biological risk exposure), obstetrics data (gestational age at the time of the interview, obstetric history like miscarriage, previous pregnancy) and comorbidities and to identify independent features associated with negative attitude to receive the influenza vaccine, a multivariate analysis has been performed to account for the locally clustered organization of healthcare services. A stepwise procedure was used to obtain the final model; level of significance was set at P < 0.05. The socio-demographic and pregnancy characteristics of both groups, vaccinated and unvaccinated women, are reported in Table 1.

| RE SULTS
In this section, univariate analysis (Table 1) showed no statistically significant differences between the two groups, except for the trimester of pregnancy (P < 0.05).
Dealing with vaccine and Influenza's knowledge (Table 2) were entered into the stepwise multiple logistic regression analysis ( Table 3).
The analysis showed that low adherence to vaccination is asso-

| D ISCUSS I ON
This study showed that more than 95% of the respondents did not request for the vaccination against Influenza. Therefore, they take advantage of protection laws, but they do not have a perception of biological flu risk and consequently they do not ask for vaccination.
In our study, half of the women had a low-medium level of education, both well-educated and poorly-educated people may have their own reasons to not accept immunization: while the inclination of  An appropriately vaccinated professional is more likely to prescribe vaccines, and that makes more evident the need for continuing education and training; therefore, it is important for scientific societies and medical associations to improve healthcare workers' influenza coverage and formation about vaccine relevance in protecting pregnancy and their communication skills to properly inform pregnant women. 35

| Limits
This study includes a certain number of limits typical of population- this document, aims to clarify vaccination worth as a prevention tool, to improve knowledge on immunization and to highlight health care workers' role in promoting vaccination.

ACK N OWLED G EM ENTS
This research was supported by the Università Politecnica delle Marche (Ancona, italy).

CO N FLI C T O F I NTE R E S T
Authors have no actual or potential conflicts of interest related to the submitted manuscript.