KOSS: Pandemic COVID-19 in pregnancy

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection) in pregnant women; Pregnancy and Childbirth

• Registration Number: ISRCTN40092247
• Lead Sponsor: niversity of Oxford

Brief Summary

2020 Results article in https://doi.org/10.1136/bmj.m2107 results (added 10/06/2020) 2021 Preprint results in https://doi.org/10.1101/2021.07.22.21261000 Impact of SARS-CoV-2 variant (added 31/08/2021) 2022 Interim results article in http://dx.doi.org/10.1136/bmjmed-2021-000053 comparison between outcomes collected in the periods in which wildtype, alpha variant, and delta variant of SARS-CoV-2 were dominant in the UK (added 09/03/2022) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33951100/ population level data on risk factors, incidence and impact of SARS-CoV-2 infection in pregnant women (added 09/03/2022) 2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35213734/ secondary analysis of data (added 09/03/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36936599/ (added 21/03/2023) 2024 Results article in https://doi.org/10.1038/s41467-024-47181-z (added 10/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study Completion: 2023-03-31
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 427

Inclusion Criteria

1. Any pregnant woman hospitalised who has tested positive for COVID-19 will be included.
2. Aged 16-45 years.

Exclusion Criteria

1. Any woman not meeting the criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pandemic COVID-19 in pregnancy assessed as proportion of pregnant women hospitalised with confirmed COVID-19 disease per 100,000 maternities during the study period

Secondary Outcome Measures

Name	Time	Method
1. Maternal death assessed using medical records from entry into the study until 6 weeks after giving birth or the end of pregnancy<br>2. Other major complication (critical care unit admission, receipt of extracorporeal membrane oxygenation [ECMO], confirmed pneumonia on imaging) assessed using medical records from entry into the study until death or hospital discharge<br>3. Perinatal death assessed using medical records as proportion of babies of pregnant women hospitalised with confirmed COVID-19 who were stillborn at 24 weeks or greater gestation, or who died in the first 7 days of life, per 1000 total births