Pregnant Women Vaccinated Against Covid-19. (COVACPREG)

Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.

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 Overview

• Status: Completed
• Conditions: Pregnant Women Vaccinated Against Covid-19
• Intervention / Treatment: Other: Patient's consent; Other: Inclusion form; Other: Adverse reaction report form.; Diagnostic test: Follow-up report form.

• Study Type: Observational
• Enrollment (Actual): 1393

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69424
    • Service Hospitalo-Universitaire de Pharmacotoxicologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Any pregnant woman who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Judith COTTIN, Service Hospitalo-Universitaire de Pharmacotoxicologie

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 69HCL21_0627; 2021-A01523-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No