COVACPREG: Pregnant Women Vaccinated Against Covid-19.

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04957953

Collaborator

(none)

1,393

Enrollment

Location

Anticipated Duration (Months)

87.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women Vaccinated Against Covid-19	Other: Patient's consent Other: Inclusion form Other: Adverse reaction report form. Diagnostic Test: Follow-up report form.

Study Design

Study Type:

Observational

Actual Enrollment :

1393 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.

Actual Study Start Date :

Dec 2, 2021

Anticipated Primary Completion Date :

Apr 2, 2023

Anticipated Study Completion Date :

Apr 2, 2023

Arms and Interventions

Arm	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.)

Arm

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.)

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service Hospitalo-Universitaire de Pharmacotoxicologie	Lyon		France	69424

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Judith COTTIN, Service Hospitalo-Universitaire de Pharmacotoxicologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04957953

Other Study ID Numbers:

69HCL21_0627
2021-A01523-38

First Posted:

Jul 12, 2021

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 20, 2022