COVID-19 and Pregnancy Outcomes

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

• Registration Number: NCT04416373
• Lead Sponsor: Universidade Nova de Lisboa

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.

Study Timeline

• Study Start: 2020-03-22
• Study First Submitted: 2020-05-29
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.

Exclusion Criteria

RT PCR SARS-CoV-2 negative.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 Neonatal Infection	7 days	Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Secondary Outcome Measures

Name	Time	Method
Perinatal mortality	35 weeks	stillbirths and deaths in the first week of life
ICU maternal admission	35 weeks	maternal ICU admission due to COVID-19
5 minute Apgar Score < 7	1 day	Newborn 5 minute Apgar Score \< 7
Preterm labour	35 weeks	Delivery between 24 and 36 weeks
PPROM	35 weeks	Preterm premature rupture of the membranes between 24 and 36 weeks
Miscarriage	14 weeks	spontaneous pregnancy loss before 24 weeks

Trial Locations

Locations (1)

Nova Medical School - UNL; 🇵🇹 Lisbon, Portugal