Study protocol: a randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3)

Sarah Rose Murray*, Jessica Thompson*, Rosie C Townsend, Manuela Deidda, Kathleen Anne Boyd, Jane E Norman, John Norrie, James P Boardman, Karen Luyt, Asma Khalil, Debra Bick, Keith Reed, Jane Denton, Natasha Fenwick, Catriona Keerie, Rebecca Reynolds, Sarah Jane Stock

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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.
Original languageEnglish
Pages (from-to)1-6
JournalBMJ Open
Volume14
DOIs
Publication statusPublished - 18 Jan 2024

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