Obstetric and Perinatal Outcomes of Women With COVID-19

Completed

• Conditions: Pregnant Women
• Interventions: Behavioral: Examine the impact of COVID-19 during pregnancy

• Registration Number: NCT04369859
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study Start: 2020-04-23
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 556

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women with COVID-19	Examine the impact of COVID-19 during pregnancy	Pregnant women who have tested positive for COVID-19

Primary Outcome Measures

Name	Time	Method
Compare the complications rates	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 Outcome Measures

Name	Time	Method
Clinical presentation	12 months	To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, Paca, France