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OpenTrials
Completed

NCT Number: NCT04957953

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.

Completed

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Key information

Conditions

Pregnant Women Vaccinated Against Covid-19

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Service Hospitalo-Universitaire de Pharmacotoxicologie

Lyon, 69424, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient's consent

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

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.

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.

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.)

Primary outcomes

  1. To assess the potential effects of vaccines on the course of pregnancy.

    Time frame: One month after injection

    Pregnancy outcomes including the rate of spontaneous miscarriage, fetal death in utero, stillbirth

  2. To assess the potential effects of vaccines on the fetus or newborn

    Time frame: One month after injection

    Characteristics of newborns (weight, height etc.) Malformation rate

  3. To assess the potential effects of vaccines on the mother.

    Time frame: One month after injection

    Rates and types of adverse events following vaccination in pregnant women vaccinated against COVID 19

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.

Acronym: COVACPREG

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2021
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.