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Severe respiratory virus infection in pregnancy and participating in the RECOVERY or REMAP-CAP Trial

Key points

  • Pregnant women are eligible to be recruited to most arms of the RECOVERY or REMAP-CAP Trials.
  • Observational pregnancy outcomes data has previously been collected for pregnant RECOVERY participants through the UKOSS Covid-19 in pregnancy study.
  • This study will allow for the continued collection of pregnancy outcome data for pregnant women participating in the RECOVERY or REMAP-CAP trials.

Surveillance period

1st April 2022 – 30th June 2026

Background

The RECOVERY Trial is an international clinical trial which aims to identify effective treatments for those hospitalised with Covid-19(1). Pregnant women are known to be at risk of severe infection with respiratory virus, and have been eligible to be recruited to most arms of the RECOVERY trial. Observational pregnancy outcome data for previous RECOVERY participants was collected through the UKOSS Covid-19 study and their outcomes compared with the cohort of women with Covid-19 as a whole. These detailed pregnancy data also describe their characteristics and management including other aspects of care for severe respiratory infection in pregnancy. The purpose of this study is to allow for the continued collection of observational pregnancy outcome data going forward as RECOVERY opens new arms to women with other severe respiratory infections, including influenza, to describe their characteristics and management including other aspects of care for severe respiratory infection in pregnancy and to compare their outcomes with previously collected UKOSS information on women with seasonal influenza or Covid-19 in pregnancy.

The REMAP-CAP Trial (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia) is an international adaptive platform to evaluate multiple treatment options for patients who are critically ill due to community-acquired pneumonia (CAP). The REMAP-CAP trial has approval for a new low-dose dexamethasone comparison for patients with CAP without suspected SARS-COV-2 or flu (therefore probable bacterial infection) and this and other CAP comparisons are open to pregnant and breastfeeding women. The UKOSS study will be examining outcomes for pregnant women participating in this arm of the REMAP-CAP trial(2).

Objective

To use the UK Obstetric Surveillance System (UKOSS) to describe the incidence, risk factors, current management and outcomes of pregnant women participating in the RECOVERY or REMAP-CAP Trials.

Research questions

  • What is the incidence of pregnant women participating in the RECOVERY or REMAP-CAP Trials in the UK?
  • What are the maternal and neonatal outcomes of pregnancy in women who have participated in the RECOVERY or REMAP-CAP Trials?

Case definition

Any woman admitted to hospital in pregnancy and participating in the RECOVERY or REMAP-CAP Trial.

Funding

This study is supported by the portfolio funders to the RECOVERY and REMAP-CAP trials.

Ethics committee approval

This study has been approved by the North London Brent REC (Ref. Number: 10/H0717/20).

Lead investigator

Prof. Marian Knight, National Perinatal Epidemiology Unit, University of Oxford

Sample Data Collection Form

UKOSS RECOVERY DCF

References

  1. www.recoverytrial.net
  2. www.remapcap.org

Updated: Tuesday, 16 July 2024 08:48 (v12)

Contact us

For more information about UKOSS, please view the contact details page