Obstetric and Perinatal Outcomes of Women With COVID-19

Pregnant Women Clinical Trial

— GROCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369859
• Other study ID #: 2020-18
• Secondary ID: ID RCB
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Behavioral:
• Examine the impact of COVID-19 during pregnancy
clinical data collection

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical presentation	To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation	12 months