COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breastfeeding
- Sponsor
- Universidade Nova de Lisboa
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- SARS-CoV-2 Neonatal Infection
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women infected with Sars-Cov-
- •Delivery at Portuguese maternities.
Exclusion Criteria
- •RT PCR SARS-CoV-2 negative.
Outcomes
Primary Outcomes
SARS-CoV-2 Neonatal Infection
Time Frame: 7 days
Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
Secondary Outcomes
- Perinatal mortality(35 weeks)
- ICU maternal admission(35 weeks)
- 5 minute Apgar Score < 7(1 day)
- Preterm labour(35 weeks)
- PPROM(35 weeks)
- Miscarriage(14 weeks)