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Pregnant Women Vaccinated Against Covid-19. (COVACPREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04957953
Recruitment Status : Active, not recruiting
First Posted : July 12, 2021
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
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
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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 : December 2, 2021
Estimated Primary Completion Date : April 2, 2023
Estimated Study Completion Date : April 2, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.)


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04957953


Locations
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France
Service Hospitalo-Universitaire de Pharmacotoxicologie
Lyon, France, 69424
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Judith COTTIN Service Hospitalo-Universitaire de Pharmacotoxicologie
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04957953    
Other Study ID Numbers: 69HCL21_0627
2021-A01523-38 ( Other Identifier: ID-RCB )
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases