Pregnant Women Vaccinated Against Covid-19.
Completed
- Conditions
- Pregnant Women Vaccinated Against Covid-19
- Registration Number
- NCT04957953
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Establish a cohort of pregnant women exposed to a COVID19 vaccine, whether or not they have experienced an adverse event, to assess the potential effects of vaccines on the course of pregnancy, on the fetus or newborn and on the mother.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1393
Inclusion Criteria
- Patient aged 18 years and over,
- Pregnant,
- Vaccinated against COVID-19,
- Not having expressed any objection to inclusion in the cohort
Exclusion Criteria
- No agreement at inclusion,
- Age under 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the potential effects of vaccines on the mother. One month after injection Rates and types of adverse events following vaccination in pregnant women vaccinated against COVID 19
To assess the potential effects of vaccines on the course of pregnancy. One month after injection Pregnancy outcomes including the rate of spontaneous miscarriage, fetal death in utero, stillbirth
To assess the potential effects of vaccines on the fetus or newborn One month after injection Characteristics of newborns (weight, height etc.) Malformation rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service Hospitalo-Universitaire de Pharmacotoxicologie
🇫🇷Lyon, France
Service Hospitalo-Universitaire de Pharmacotoxicologie🇫🇷Lyon, France