An observational study in Vaccination Coverage Among Pregnant Women, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
The objective of this study is to assess vaccination coverage (VC) for vaccines recommended during pregnancy (pertussis, COVID-19, seasonal influenza, and respiratory syncytial virus [RSV] infection), their acceptability, and the factors associated with this acceptability among pregnant women and healthcare professionals in several maternity units in the Île-de-France region. We plan to estimate vaccination coverage using health-related (type of follow-up) and relevant socio-educational strata at the regional level in Île-de-France. An overall estimate of vaccination coverage for the Île-de-France region will be obtained by weighting according to regional data for these strata. Estimates of vaccination coverage according to determinants-particularly socio-educational factors-will allow extrapolation to other French regions, in order to better define strategies for promoting vaccination among pregnant women and the healthcare professionals who care for them. The wide diversity of maternity unit profiles in Île-de-France, together with the substantial socio-educational diversity of the regional population, will enable a nuanced and comprehensive overview.
Certain infections occurring during pregnancy may lead to sometimes severe maternal, obstetric, fetal, and/or neonatal complications. Pregnant women experience higher morbidity and mortality in cases of COVID-19 or influenza infection compared with the general population. Furthermore, pertussis and seasonal influenza are associated with higher morbidity and mortality in newborns and infants than in the general population. In addition, respiratory syncytial virus (RSV) infection-the leading cause of lower respiratory tract infections in newborns and infants-may result in severe bronchiolitis and places a substantial burden on the healthcare system during winter epidemic periods.
Maternal vaccination provides protection for the mother (vaccination against COVID-19 and seasonal influenza) and protects the newborn and infant through the transplacental transfer of specific antibodies (vaccination against pertussis, seasonal influenza, and RSV infection). Vaccines against pertussis, COVID-19, seasonal influenza, and RSV infection are specifically recommended during pregnancy. In France, seasonal influenza vaccination coverage (VC) among pregnant women remains low (30.4%). Pertussis vaccination coverage among pregnant women, estimated using data from the French National Health Data System (SNDS), is 63.2%.
In France, acceptability of vaccination during pregnancy against pertussis, seasonal influenza, COVID-19, and RSV was estimated at 36.1%, 43.9%, 36.8%, and 39.4%, respectively, in a single-center observational study conducted prior to the publication of vaccination recommendations for pertussis and RSV infection. One of the key factors promoting acceptability of these vaccinations is recommendation by healthcare professionals involved in the care of pregnant women. According to data from the 2021 French National Perinatal Survey, the main reason for non-vaccination against seasonal influenza among pregnant women was the absence of a vaccination proposal from a healthcare professional, reported by nearly half of respondents (41.4%).
Improving vaccination coverage among pregnant women and identifying the determinants of such coverage represent a major public health challenge. To date, no study conducted in France has simultaneously assessed vaccination coverage for pertussis, COVID-19, seasonal influenza, and RSV infection in maternity settings. Moreover, no study has yet evaluated the determinants of vaccination against pertussis, COVID-19, and RSV infection among pregnant women following the publication of new vaccination recommendations during pregnancy by the French National Authority for Health (Haute Autorité de Santé).
246 studies on the registry are indexed under Whooping Cough; 16 are open to participants now.
This study's planned enrollment of 1,605 is above the median of 538 across 58 observational studies indexed under Whooping Cough.
Browse Whooping Cough studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Two maternity units per Île-de-France department, for a total of 16 maternity units, as follows:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Postpartum women:
Healthcare professionals :
Exclusion Criteria :
- Postpartum women :
Women aged 18 years and older, in the immediate postpartum period, having given birth to one or more live infants beyond 36 weeks of gestation.
Vaccinating physicians, midwives, or nurses providing pregnancy follow-up in a participating maternity unit.
Survey to Estimate Vaccination Coverage Against Pertussis, COVID-19, Seasonal Influenza, and RSV Infection Among Pregnant Women in Maternity Units in the Île-de-France Region.
Proportion of women vaccinated against pertussis, COVID-19, seasonal influenza, and RSV infection during pregnancy, by department type and by maternity unit type, and then estimate the proportion of vaccinated women across the entire Île-de-France region.
Time frame: Day 0
Survey to determine the proportion of newborns who received RSV immunization through the administration of specific monoclonal antibodies
Proportion of newborns immunized against RSV through administration of specific monoclonal antibodies, born to mothers who were not vaccinated against RSV during pregnancy.
Time frame: Day 0
Survey to assess knowledge of vaccination recommendations for pertussis, COVID-19, RSV, and seasonal influenza during pregnancy
Proportion of women aware of vaccination recommendations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy, and their sources of information.
Time frame: Day 0
Questionnaire aimed at assessing the proportion of women who are aware of the recommendation for preventive immunization of newborns against RSV as well as identifying their main sources of information.
Proportion of women aware of the recommendation for pre-exposure immunization against RSV through administration of monoclonal antibodies-nirsevimab (Beyfortus®) or palivizumab (Synagis®)-to the newborn, and their sources of information.
Time frame: Day 0
Questionnaire to Identify Factors Associated with Vaccination Against Pertussis, COVID-19, Seasonal Influenza, and RSV During Pregnancy
Vaccination status, knowledge of the listed infections, knowledge of vaccines, vaccination pathway, socio-demographic and socio-economic factors, category of healthcare professional providing pregnancy care.
Time frame: Day 0
Questionnaire to identify factors associated with pre-exposure vaccination against RSV through the administration of monoclonal antibodies to newborns
Factors associated with pre-exposure immunization against RSV through administration of monoclonal antibodies-nirsevimab (Beyfortus®) or palivizumab (Synagis®)-to the newborn.
Time frame: Day 0
Questionnaire to assess the acceptability of vaccination against pertussis, COVID-19, and seasonal influenza in the context of a future pregnancy.
Proportion of women who accepted vaccination against pertussis, COVID-19, and/or seasonal influenza during their pregnancy and who would accept the same vaccination(s) again in a future pregnancy.
Time frame: Day 0
Questionnaire to assess the acceptability of various strategies for preventing RSV and bronchiolitis in newborns in the context of a future pregnancy or birth
Proportion of women whose newborn was immunized against RSV and who would accept either RSV immunization strategy in a future pregnancy/birth
Time frame: Day 0
For women not vaccinated against pertussis during pregnancy, assess: • Reasons for non-vaccination against pertussis. • Acceptability of vaccination against pertussis during pregnancy and postpartum. • Barriers to vaccination against pertussis.
Proportion of women not vaccinated against COVID-19, seasonal influenza, and/or RSV during pregnancy who: i) would have accepted one or more of these vaccinations during that pregnancy, ii) would accept one or more of these vaccinations in a future pregnancy.
Time frame: Day 0
Survey to determine the proportion of women who were not vaccinated against COVID-19, seasonal flu, and/or RSV during their pregnancy and who would have agreed or would agree to receive one or more of these vaccines
Proportion of women not vaccinated against COVID-19, seasonal influenza, and/or RSV during pregnancy who: I) would have accepted one or more of these vaccinations during that pregnancy, II) would accept one or more of these vaccinations in a future pregnancy.
Time frame: Day 0
Questionnaire to assess the acceptability of various strategies for preventing RSV and bronchiolitis in newborns in the context of a future pregnancy or birth
Proportion of women whose newborn was not immunized against RSV who: I) would have accepted either RSV immunization strategy during this pregnancy/birth, II) would accept either RSV immunization strategy in a future pregnancy/birth.
Time frame: Day 0
Questionnaire to assess the reasons for non-vaccination during pregnancy
Reasons for non-vaccination against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy (not offered/refusal/other).
Time frame: Day 0
Survey to describe the vaccination history of pregnant women regarding pertussis, COVID-19, seasonal flu, and RSV
For women vaccinated during pregnancy: * Professional category and practice setting of the healthcare professional who prescribed the vaccination to the pregnant woman (physician, nurse, midwife, pharmacist; maternity unit or community setting). * Professional category and practice setting of the healthcare professional who administered the vaccination to the pregnant woman (physician, nurse, midwife, pharmacist; maternity unit or community setting).
Time frame: Day 0
Survey to determine the vaccination coverage rate for pertussis, seasonal flu, and COVID-19.
Proportion of vaccinating healthcare professionals up to date with their own vaccinations against pertussis, COVID-19, and seasonal influenza.
Time frame: Day 0
Questionnaire to Identify Factors Associated with Pertussis, COVID-19, and Seasonal Flu Vaccinations Administered by Primary Care Providers
Vaccination status, knowledge of the listed infections, knowledge of vaccines, vaccination pathway, socio-demographic and socio-economic factors.
Time frame: Day 0
Questionnaire to assess knowledge of vaccination recommendations for pertussis, COVID-19, seasonal influenza, and RSV during pregnancy.
Proportion of vaccinating healthcare professionals aware of vaccination recommendations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy, and their sources of information.
Time frame: Day 0
Questionnaire to assess whether healthcare professionals are offering recommended vaccines to pregnant women
Proportion of vaccinating healthcare professionals offering vaccinations against pertussis, COVID-19, seasonal influenza, and RSV to pregnant women.
Time frame: Day 0
Surveys to assess how often healthcare professionals responsible for vaccinations prescribe vaccines during pregnancy.
Frequency with which vaccinating healthcare professionals prescribe vaccinations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy (never, sometimes, often, always).
Time frame: Day 0
Questionnaire to assess the factors associated with prescribing vaccines "often" or "always" during pregnancy.
Factors associated with "often" or "always" prescribing vaccinations against pertussis, COVID-19, seasonal influenza, and RSV to pregnant women (vaccination status of the healthcare professional for influenza, pertussis, and COVID-19; knowledge of the healthcare professional regarding pertussis; knowledge of the healthcare professional regarding national vaccination recommendations for pregnant women).
Time frame: Day 0
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 21 observational studies under Whooping Cough, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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