why choose us

300×250 Ad Slot

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

Date Published: 2024-01-18

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 .

Introduction:
The overall aim of STOPPIT-3 is to address the uncertainty regarding the effectiveness of antenatal corticosteroids (ACS) prior to a planned birth of twins in the late preterm and early term period. ACS are widely administered via intramuscular (IM) injection to women at risk of preterm birth (defined as birth less than 37 completed weeks gestation) to reduce morbidity and mortality in babies born too early 1 and have been recommended since the 1990s. ACS are known to be most effective if birth occurs 24–48?hours…

Read more

300×250 Ad Slot