A global registry of women affected by COVID-19 in pregnancy and their babies, to guide treatment and preventio
Not Applicable
Completed
- Conditions
- COVID-19 (SARS-CoV-2 infection) in pregnancy and neonatesInfections and Infestations
- Registration Number
- ISRCTN68026880
- Lead Sponsor
- Imperial College London
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33514576/ protocol (added 01/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35914420/ (added 28/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8239
Inclusion Criteria
1. Women aged 18-50 who are pregnant and their babies
2. Suspected COVID-19 or confirmed SARs-CoV-2 infection
3. Delivery or pregnancy loss between January 2020 and March 2021
Exclusion Criteria
Individuals who do not meet the inclusion criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Confirmed SARS-CoV-2 infection in women in pregnancy or their neonates, measured using routine clinical data from 01/01/2020 to 31/03/2021<br>2. Suspected SARS-CoV-2 (defined as woman self-isolating for suspected COVID-19 with symptoms, symptoms will be recorded) measured using routine clinical data from 01/01/2020 to 31/03/2021
- Secondary Outcome Measures
Name Time Method 1. Incidence of miscarriage measured using routine clinical data from 01/01/2020 to 31/3/2021<br>2. Incidence of fetal growth restriction and stillbirth measured using routine clinical data from 01/01/2020 to 31/3/2021<br>3. Incidence of preterm birth measured using routine clinical data from 01/01/2020 to 31/3/2021<br>4. Incidence of vertical transmission to the neonate measured using routine clinical data from 01/01/2020 to 31/3/2021<br>5. Co-morbidities measured using routine clinical data from 01/01/2020 to 31/3/2021<br>6. Medical history measured using routine clinical data from 01/01/2020 to 31/3/2021<br>7. Details of the delivery of baby/babies measured using routine clinical data from 01/01/2020 to 31/3/2021