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NCT04416373 Clinical Trial

COVID-19 and Pregnancy Outcomes

Breastfeeding Clinical Trial

— COVID&PREG  

Official title:
COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04416373
Other study ID # COVID&PREG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2020
Est. completion date December 2023

Study information
Verified date June 2020
Source Universidade Nova de Lisboa
Contact Nadia Charepe, MD,MSc
Phone 00351213184000
Email nadia.charepe@chlc.min-saude.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 55 Years
Eligibility Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.

Exclusion Criteria: RT PCR SARS-CoV-2 negative.

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Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Portugal Nova Medical School - UNL Lisbon

Sponsors (1)
Lead Sponsor Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2 Neonatal Infection Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples 7 days
Secondary Perinatal mortality stillbirths and deaths in the first week of life 35 weeks
Secondary ICU maternal admission maternal ICU admission due to COVID-19 35 weeks
Secondary 5 minute Apgar Score < 7 Newborn 5 minute Apgar Score < 7 1 day
Secondary Preterm labour Delivery between 24 and 36 weeks 35 weeks
Secondary PPROM Preterm premature rupture of the membranes between 24 and 36 weeks 35 weeks
Secondary Miscarriage spontaneous pregnancy loss before 24 weeks 14 weeks
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