NCT04416373

COVID-19 and Pregnancy Outcomes

COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Detailed description

This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study. Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.

Conditions

• Coronavirus Infection
• Pregnancy Complications
• Vertical Transmission of Infectious Disease
• Breastfeeding
• Neonatal Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RT PCR SARS-CoV-2	Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Timeline

• Start date: 2020-03-22
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

1 site across 1 country: Portugal