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Trial · NCT07882186

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySurvey 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.Day 0
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.
SecondarySurvey to determine the proportion of newborns who received RSV immunization through the administration of specific monoclonal antibodiesDay 0Proportion of newborns immunized against RSV through administration of specific monoclonal antibodies, born to mothers who were not vaccinated against RSV during pregnancy.
SecondarySurvey to assess knowledge of vaccination recommendations for pertussis, COVID-19, RSV, and seasonal influenza during pregnancyDay 0Proportion of women aware of vaccination recommendations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy, and their sources of information.
Secondary
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.
Day 0
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.
SecondaryQuestionnaire to Identify Factors Associated with Vaccination Against Pertussis, COVID-19, Seasonal Influenza, and RSV During PregnancyDay 0
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.
SecondaryQuestionnaire to identify factors associated with pre-exposure vaccination against RSV through the administration of monoclonal antibodies to newbornsDay 0Factors associated with pre-exposure immunization against RSV through administration of monoclonal antibodies-nirsevimab (Beyfortus®) or palivizumab (Synagis®)-to the newborn.
SecondaryQuestionnaire to assess the acceptability of vaccination against pertussis, COVID-19, and seasonal influenza in the context of a future pregnancy.Day 0Proportion 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.
SecondaryQuestionnaire to assess the acceptability of various strategies for preventing RSV and bronchiolitis in newborns in the context of a future pregnancy or birthDay 0Proportion of women whose newborn was immunized against RSV and who would accept either RSV immunization strategy in a future pregnancy/birth
Secondary
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.
Day 0
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.
Secondary
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
Day 0
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.
SecondaryQuestionnaire to assess the acceptability of various strategies for preventing RSV and bronchiolitis in newborns in the context of a future pregnancy or birthDay 0
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.
SecondaryQuestionnaire to assess the reasons for non-vaccination during pregnancyDay 0Reasons for non-vaccination against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy (not offered/refusal/other).
SecondarySurvey to describe the vaccination history of pregnant women regarding pertussis, COVID-19, seasonal flu, and RSVDay 0
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).
SecondarySurvey to determine the vaccination coverage rate for pertussis, seasonal flu, and COVID-19.Day 0Proportion of vaccinating healthcare professionals up to date with their own vaccinations against pertussis, COVID-19, and seasonal influenza.
SecondaryQuestionnaire to Identify Factors Associated with Pertussis, COVID-19, and Seasonal Flu Vaccinations Administered by Primary Care ProvidersDay 0Vaccination status, knowledge of the listed infections, knowledge of vaccines, vaccination pathway, socio-demographic and socio-economic factors.
SecondaryQuestionnaire to assess knowledge of vaccination recommendations for pertussis, COVID-19, seasonal influenza, and RSV during pregnancy.Day 0Proportion of vaccinating healthcare professionals aware of vaccination recommendations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy, and their sources of information.
SecondaryQuestionnaire to assess whether healthcare professionals are offering recommended vaccines to pregnant womenDay 0Proportion of vaccinating healthcare professionals offering vaccinations against pertussis, COVID-19, seasonal influenza, and RSV to pregnant women.
SecondarySurveys to assess how often healthcare professionals responsible for vaccinations prescribe vaccines during pregnancy.Day 0Frequency with which vaccinating healthcare professionals prescribe vaccinations against pertussis, COVID-19, seasonal influenza, and RSV during pregnancy (never, sometimes, often, always).
SecondaryQuestionnaire to assess the factors associated with prescribing vaccines "often" or "always" during pregnancy.Day 0
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).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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