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Pregnant Women Vaccinated Against Covid-19.

Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04957953
Acronym
COVACPREG
Enrollment
1393
Registered
2021-07-12
Start date
2021-12-02
Completion date
2022-12-13
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women Vaccinated Against Covid-19

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.

Interventions

OTHERPatient'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.

OTHERInclusion 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.

OTHERAdverse 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_TESTFollow-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.)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
To assess the potential effects of vaccines on the course of pregnancy.One month after injectionPregnancy outcomes including the rate of spontaneous miscarriage, fetal death in utero, stillbirth
To assess the potential effects of vaccines on the fetus or newbornOne month after injectionCharacteristics of newborns (weight, height etc.) Malformation rate
To assess the potential effects of vaccines on the mother.One month after injectionRates and types of adverse events following vaccination in pregnant women vaccinated against COVID 19

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026