Pregnant Women Vaccinated Against Covid-19.

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.

Conditions
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Pregnant Women Vaccinated Against Covid-19

Intervention / Treatment
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* Other: Patient's consent
* Other: Inclusion form
* Other: Adverse reaction report form.
* Diagnostic Test: Follow-up report form.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women Vaccinated against Covid-19<br>Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy. | Other: Patient's consent<br>* 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.<br>Other: Inclusion form<br>* 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.<br>Other: Adverse reaction report form.<br>* 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,<br>Diagnostic Test: Follow-up report form.<br>* 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.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One month after injection | 
| To assess the potential effects of vaccines on the fetus or newborn | Characteristics of newborns (weight, height etc.) Malformation rate | 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 | One month after injection |