Breastfeeding Clinical Trial
— COVID&PREGOfficial title:
COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
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 |
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.
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. - |
Country | Name | City | State |
---|---|---|---|
Portugal | Nova Medical School - UNL | Lisbon |
Lead Sponsor | Collaborator |
---|---|
Universidade Nova de Lisboa |
Portugal,
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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