Pregnant Women Vaccinated Against Covid-19.

CompletedOBSERVATIONAL
Enrollment

1,393

Participants

Timeline

Start Date

December 2, 2021

Primary Completion Date

December 13, 2022

Study Completion Date

December 13, 2022

Conditions
Pregnant Women Vaccinated Against Covid-19
Interventions
OTHER

Patient's consent

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.

OTHER

Inclusion form

"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."

OTHER

Adverse reaction report form.

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,

DIAGNOSTIC_TEST

Follow-up report form.

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.)

Trial Locations (1)

69424

Service Hospitalo-Universitaire de Pharmacotoxicologie, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04957953 - Pregnant Women Vaccinated Against Covid-19. | Biotech Hunter | Biotech Hunter