NCT04369859

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

April 29, 2020

Last Update Submit

February 9, 2022

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Compare the complications rates

    To compare the complications rates of pregnant women tested positive for the SARS-CoV-2 (study group), with reference rates in a Covid-free population.

    12 months

Secondary Outcomes (1)

  • Clinical presentation

    12 months

Study Arms (1)

pregnant women with COVID-19

Pregnant women who have tested positive for COVID-19

Behavioral: Examine the impact of COVID-19 during pregnancy

Interventions

Examine the impact of COVID-19 during pregnancyBEHAVIORAL

clinical data collection

pregnant women with COVID-19

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons assigned gender female at birth
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases will be recruited among all pregnant women aged \>18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South regional perinatology network

You may qualify if:

  • Pregnant women
  • Able to give informed consent
  • Diagnosed with COVID-19

You may not qualify if:

  • Patients Refusing to Participate in the Study
  • Patients who do not speak French well enough to benefit from clear and intelligible information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, PACA, 13354, France

Location

Study Officials

  • Jean-Olivier ARNAUD, Director

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

April 30, 2020

Study Start

April 23, 2020

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

February 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)