Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol

Murray, S. et al. (2024) Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol. BMJ Open, 14(1), e078778. (doi: 10.1136/bmjopen-2023-078778) (PMID:38238048) (PMCID:PMC10806667)

Abstract

Introduction: The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot. Methods and analysis: This study will comprise a multicentre, double-blinded, randomised, placebo-controlled trial in at least 50 UK obstetric units. The target population is 1552 women with a twin pregnancy and a planned birth between 35 and 38+6 weeks’ gestation recruited from antenatal clinics. Women will be randomised to Dexamethasone Phosphate (24 mg) or saline administered via two intramuscular injections 24 hours apart, 24–120 hours prior to scheduled birth. Outcomes: The primary outcome is need for respiratory support within 72 hours of birth. Secondary and safety outcomes will be included. Cognitive and language development at age 2 years will be assessed in a subset of participants using the Parent report of Children’s Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo. Ethics and dissemination: STOPPIT-3 has been funded and approved by the National Institute of Healthcare Research. It has been approved by the West Midlands Research Ethics Committee (22/WM/0018). The results will be disseminated via publication in peer-reviewed journals and conference presentation and will also be communicated to the public via links with charity partners and social media. Trial sponsor: The University of Edinburgh and Lothian Health Board ACCORD, The Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ. Trial registration number: ISRCTN59959611.

• Item Type: Articles
• Additional Information: Funding: This work was supported by the National Institute of Healthcare Research Health Technology Assessment grant number: NIHR131352.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Boyd, Professor Kathleen and Deidda, Dr Manuela
• Authors: Murray, S., Thompson, J., Townsend, R. C., Deidda, M., Boyd, K. A., Norman, J. E., Norrie, J., Boardman, J. P., Luyt, K., Khalil, A., Bick, D., Reed, K., Denton, J., Fenwick, N., Keerie, C., Reynolds, R., and Stock, S. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Published Online: 18 January 2024
• Copyright Holders: Copyright © Author(s) (or their employer(s)) 2024
• First Published: First published in BMJ Open 14(1):e078778
• Publisher Policy: Reproduced under a Creative Commons license