Breastfeeding, Coronavirus Infection, Neonatal Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTRT PCR SARS-CoV-2
Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
Sponsors
Universidade Nova de Lisboa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.
Exclusion criteria
RT PCR SARS-CoV-2 negative. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Perinatal mortality | 35 weeks | stillbirths and deaths in the first week of life |
| PPROM | 35 weeks | Preterm premature rupture of the membranes between 24 and 36 weeks |
| Miscarriage | 14 weeks | spontaneous pregnancy loss before 24 weeks |
| Preterm labour | 35 weeks | Delivery between 24 and 36 weeks |
Countries
Portugal
Contacts
Primary ContactNadia Charepe, MD,MSc
Backup ContactAlexandra Queirós, MD
Outcome results
None listed