Pregnant Women Vaccinated Against Covid-19.

NCT ID: NCT04957953

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1393 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-12-13

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.

Conditions

Pregnant Women Vaccinated Against Covid-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant Women Vaccinated against Covid-19

Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.

Patient's consent

Intervention Type: OTHER

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.

Inclusion form

Intervention Type: OTHER

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.

Adverse reaction report form.

Intervention Type: OTHER

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,

Follow-up report form.

Intervention Type: DIAGNOSTIC_TEST

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.)

Interventions

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.

Intervention Type: 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.

Intervention Type: 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,

Intervention Type: OTHER

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.)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith COTTIN

Role: PRINCIPAL_INVESTIGATOR

Service Hospitalo-Universitaire de Pharmacotoxicologie

Locations

Service Hospitalo-Universitaire de Pharmacotoxicologie

Lyon, , France

Countries

France

Other Identifiers

2021-A01523-38

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0627

Identifier Type: -

Identifier Source: org_study_id