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Clinical Trials/NCT04369859
NCT04369859
Completed
Not Applicable

Obstetric and Perinatal Outcomes of Women With COVID-19: A Prospective Cohort Study

Assistance Publique Hopitaux De Marseille1 site in 1 country556 target enrollmentApril 23, 2020
ConditionsPregnant Women

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnant Women
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
556
Locations
1
Primary Endpoint
Compare the complications rates
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

Clinical manifestations of COVID-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ARDS), fatal in 1% of cases. However, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (SARS-CoV and MERS-CoV). 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. Voluntary physicians will refer eligible participants to the study-coordinating center at APHM University Hospital. The participants will be followed by phone after having provided an informed consent. Clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Registry
clinicaltrials.gov
Start Date
April 23, 2020
End Date
January 15, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Compare the complications rates

Time Frame: 12 months

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.

Secondary Outcomes

  • Clinical presentation(12 months)

Study Sites (1)

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