Clinical Trials Directory

Trials / Completed

CompletedNCT04369859

Obstetric and Perinatal Outcomes of Women With COVID-19

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

Status
Completed
Phase
Study type
Observational
Enrollment
556 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExamine the impact of COVID-19 during pregnancyclinical data collection

Timeline

Start date
2020-04-23
Primary completion
2022-01-15
Completion
2022-01-15
First posted
2020-04-30
Last updated
2022-02-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04369859. Inclusion in this directory is not an endorsement.