Vaccination Coverage Among Pregnant WomenRECOVAXNCT07882186
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
An observational study of Vaccination Coverage Among Pregnant Women, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccination Coverage Among Pregnant Women
- Type of treatment
- Vaccines
- How many people
- 1,605 participants
- Where
- 16 sitesFrance
- Study dates
- Nov 2026to Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two maternity units per Île-de-France department, for a total of 16 maternity units, as follows: * One level 3 maternity unit per department (8 in total). * One level 1 or 2 maternity unit per department (8 in total).
Who may be able to join
- Postpartum women:
- Women aged 18 years and older.
- Women in the immediate postpartum period (during the maternity stay) having given birth to one or more live-born infants.
- Women who delivered after 36 weeks of gestation.
- Healthcare professionals :
- Vaccinating healthcare professionals (physicians, midwives, or nurses) providing pregnancy care and working in a maternity unit participating in the study.
Who cannot join
- Postpartum women :
- Individuals under legal protection (guardianship, curatorship, or trusteeship).
- Women who delivered after fetal death or following a medical termination of pregnancy.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites
Hôpital privé de Marne la Vallée. Gynécologie-obstétrique. 33 R LEON MENU
Bry-sur-Marne, Île-de-France Region, 94360
Alexandra TRIE, MD, 01 77 74 15 81 ext. +33, dratrie.hpmv@gmail.com
HU Paris Sud - Site Antoine-Béclère APHP - Gynécologie-obstétrique. 157 RUE DE LA PTE DE TRIVAUX
Clamart, Île-de-France Region, 92140
Lucie CAFFIN, MD, 01 45 37 44 41 ext. +33, lucie.caffin@aphp.fr
CH Sud Francilien - Site Jean Jaurès - Gynécologie-obstétrique. 40 AV SERGE DASSAULT
Corbeil-Essonnes, Île-de-France Region, 91106
Jed DIARI, MD, 01 691 69 52 59 ext. +33, jed.diari@chst.fr
CH Général de Gonesse. Gynécologie-obstétrique. 2 BD DU 19 MARS 1962
Gonesse, Île-de-France Region, 95503
Bénédicte PAINDAVAINE, MD, 01 34 53 22 26 ext. +33, benedicte.paindaveine@ch-gonesse.fr
Hôpital privé de la Seine Saint-Denis - Gynécologie-obstétrique. 7 AV HENRI BARBUSSE
Le Blanc-Mesnil, Île-de-France Region, 93156
Armate ZERROUKI, MD, 06 19 76 10 20 ext. +33, dr.zerrouki@gmail.com
CH de Versailles - St André Mignot - Gynécologie-obstétrique. 177 R DE VERSAILLES
Le Chesnay, Île-de-France Region, 78157
Aude RIBOURG, MD, 01 39 63 80 53 ext. +33, aricbourg@ght78sud.fr
HU Paris Sud - Site Kremlin-Bicêtre- APHP. Gynécologie-obstétrique. 78 AV DU GENERAL LECLERC
Le Kremlin-Bicêtre, Île-de-France Region, 94275
Clinique de l'Yvette - Gynécologie-obstétrique. 67-71 RTE DE CORBEIL
Longjumeau, Île-de-France Region, 91160
Bérengère CANON, MD, 01 69 20 31 70 ext. +33, b.canon@hotmail.fr
CH de Meaux - Site Saint Faron - Gynécologie-obstétrique. 6-8 RUE SAINT-FIACRE
Meaux, Île-de-France Region, 77100
Abdelilah ARSALANE, MD, 01 64 35 13 19 ext. +33, aarsalane@ghef.fr
CH de Melun - Site Santepole - Gynécologie-obstétrique. 270 AV MARC JACQUET
Melun, Île-de-France Region, 77000
Fabienne JOUATE, MD, 01 81 74 19 91 ext. +33, fabienne.jouatte@ghsif.fr
CHI André Grégoire - Gynécologie-obstétrique. 56 BD DE LA BOISSIERE
Montreuil, Île-de-France Region, 93100
Simon CREQUIT, MD, 01 49 20 72 32 ext. +33, simon.crequit@ght-gpne.fr
Maternité Trousseau ( CHU) - Gynécologie-obstétrique. 26 AV DU DR ARNOLD NETTER
Paris, Île-de-France Region, 75012
Jeanne SIBIUDE, MD, PhD, 06 40 65 62 81 ext. +33, jeanne.sibiude@aphp.fr
Clinique Sainte Thérèse - Gynéologie-obstétrique. 9 R GUSTAVE DORE
Paris, Île-de-France Region, 75017
Laurène MAJOULET, MD, 01 40 54 07 87 ext. +33, dr.majoulet@gmail.com
CHI de Poissy St Germain - Site de Poissy - Gynécologie-obstétrique. 10 R DU CHAMP GAILLARD
Poissy, Île-de-France Region, 78303
Thibaud QUIBEL, MD, 01 39 27 52 57 ext. +33, thibaud.quibel@ght-yvelinesnord.fr
CH Novo - Site René Dubos. Gynécologie-obstétrique. 6 AV DE L'ILE DE FRANCE
Pontoise, Île-de-France Region, 95300
Cergika VELUPPILLAI, MD, 01 30 75 48 27 ext. +33, cergika.veluppillai@ght-novo.fr
CH des quatres villes - Site Saint-Cloud - Gynécologie -obstétrique. 3 PL SILLY
Saint-Cloud, Île-de-France Region, 92210
Yao SHEN, MD, 01 77 70 76 81 ext. +33, y.shen@ch4v.fr
About this study
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.
Read the detailed description
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).
- Keywords
- Vaccination coverage, Pregnancy, Pertussis, Covid-19, Influenza, RSV infection
- Medical subject headings
- Whooping Cough, COVID-19, Influenza, Human, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant 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. | |
| Healthcare workers | Vaccinating physicians, midwives, or nurses providing pregnancy follow-up in a participating maternity unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination Coverage Among Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, Institut de Recherche en Santé Publique, France, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- MARIE LACHATRE, Study chair, Equipe Mobile d'Infectiologie - Hôpital Cochin/APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882186
- Sponsor's protocol ID
- APHP251436
- Other IDs
- IDRCB
- Acronym
- RECOVAX
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No