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.
Keywords: Fetal medicine; NEONATOLOGY; OBSTETRICS.
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