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.
Study Type
OBSERVATIONAL
Enrollment
1,393
Primary enrolment will be carried out at the time of vaccination at the main vaccination sites, with the patient's consent. The agreement form filled in online includes the surname, first name, month and year of birth. This form serves as an agreement to participate in the study.
This form includes the date of the last menstrual period, vaccination data (type of vaccine, date of vaccination, 1st or 2nd injection, etc.), socio-demographic data of the pregnant woman, medical and surgical history, gynaecological and obstetrical history, a description of the current pregnancy, and the medication taken by the patient during her pregnancy.... A link to complete this form (with the unique identifier) will be sent to each woman included who has given her consent to participate.
Service Hospitalo-Universitaire de Pharmacotoxicologie
Lyon, France
To assess the potential effects of vaccines on the course of pregnancy.
Pregnancy outcomes including the rate of spontaneous miscarriage, fetal death in utero, stillbirth
Time frame: One month after injection
To assess the potential effects of vaccines on the fetus or newborn
Characteristics of newborns (weight, height etc.) Malformation rate
Time frame: One month after injection
To assess the potential effects of vaccines on the mother.
Rates and types of adverse events following vaccination in pregnant women vaccinated against COVID 19
Time frame: One month after injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
One month after each injection of the vaccine, information will be collected on any vaccination-related adverse reactions that may impact the pregnancy (fever, hypertension, etc.) or on the onset of a Covid-19 infection,
In the 2 months following the expected delivery date, information will be collected on the outcome of the pregnancy (delivery, spontaneous abortion, etc.) and maternal clinical signs (pre-eclampsia, gestational hypertension, gestational diabetes, etc.). Before sending the link to this form, information will be sent to the second holder of parental authority. In the absence of opposition, data on the newborn will be collected (sex, height, weight, head circumference, Apgar, malformation, neonatal pathology, etc.)