Exploratory Study: COVID-19 and Pregnancy

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Pregnant Women; Covid19

Treatments: Diagnostic Test: SARS-CoV-2 serology

Study type: Observational

Funder types: Other

Identifiers

NCT04647994

30270820.3.0000.0068

Details and patient eligibility

About

The SARS-CoV-2 infection may behave differently in pregnant and postpartum women in the short and long term. Several risk factors or medication use can interfere on disease' evolution and vertical transmission. Thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive SARS-CoV-2.

Enrollment: 500 estimated patients

Sex: Female

Ages: 17 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized or in delivery time;
• Asymptomatic pregnant women for SARS-CoV-2 during pregnancy and hospitalized for delivery at HU-USP.
• Pregnant women diagnosed with SARS-CoV-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the HU-USP or HCFMUSP.

Exclusion criteria

• Non-confirmation of maternal SARS-CoV-2 infection in pregnant women hospitalized or in delivery time.
• Withdrawal of pregnant woman to continue in the study.

Trial design

500 participants in 4 patient groups

Covid-19 HC patients

Description:

Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP.

Treatment:

Diagnostic Test: SARS-CoV-2 serology

Delivery patients

Description:

Asymptomatic pregnant women that tested SARS-CoV-2 serology (positive or negative serology) at the delivery time at Universitarian Hospital HU-USP and HC-FMUSP.

Treatment:

Diagnostic Test: SARS-CoV-2 serology

Prenatal patients

Description:

Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2.

Treatment:

Diagnostic Test: SARS-CoV-2 serology

Negative serology patients

Description:

Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2.

Treatment:

Diagnostic Test: SARS-CoV-2 serology