Pregnant Women Vaccinated Against Covid-19.

Completed

• Conditions: Pregnant Women Vaccinated Against Covid-19
• Interventions: Other: Patient's consent; Other: Inclusion form; Other: Adverse reaction report form.; Diagnostic Test: Follow-up report form.

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-12
• Study Start: 2021-12-02
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

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

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Exclusion Criteria

• No agreement at inclusion,
• Age under 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women Vaccinated against Covid-19	Inclusion form	Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.
Pregnant Women Vaccinated against Covid-19	Follow-up report form.	Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.
Pregnant Women Vaccinated against Covid-19	Patient's consent	Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.
Pregnant Women Vaccinated against Covid-19	Adverse reaction report form.	Woman over 18 years of age who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.

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

Trial Locations

Locations (1)

Service Hospitalo-Universitaire de Pharmacotoxicologie; 🇫🇷 Lyon, France