Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/1/e078778.full |
| _version_ | 1797295904086032384 |
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| author | Jane E Norman John Norrie Jane Denton James P Boardman Kathleen Anne Boyd Manuela Deidda Karen Luyt Catriona Keerie Debra Bick Asma Khalil Sarah Jane Stock Rebecca Reynolds Jessica Thompson Keith Reed Sarah Murray Rosie C Townsend Natasha Fenwick |
| author_facet | Jane E Norman John Norrie Jane Denton James P Boardman Kathleen Anne Boyd Manuela Deidda Karen Luyt Catriona Keerie Debra Bick Asma Khalil Sarah Jane Stock Rebecca Reynolds Jessica Thompson Keith Reed Sarah Murray Rosie C Townsend Natasha Fenwick |
| author_sort | Jane E Norman |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T21:55:39Z |
| format | Article |
| id | doaj.art-d634ba2ff4084285947a87f357ae376b |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-07T21:55:39Z |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-d634ba2ff4084285947a87f357ae376b2024-02-24T16:50:09ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-078778Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocolJane E Norman0John Norrie1Jane Denton2James P Boardman3Kathleen Anne Boyd4Manuela Deidda5Karen Luyt6Catriona Keerie7Debra Bick8Asma Khalil9Sarah Jane Stock10Rebecca Reynolds11Jessica Thompson12Keith Reed13Sarah Murray14Rosie C Townsend15Natasha Fenwick16University of Nottingham Executive Office, University of Nottingham, Nottingham, UKEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Bioquarter, Edinburgh, UKCo lead Elizabeth Bryan Multiple Births Centre, Imperial College London, London, UK17 Institute for Regeneration and Repair, University of Edinburgh Division of Reproductive and Developmental Sciences, Edinburgh, UKHealth Economics and Health Technology Assessment, University of Glasgow, Glasgow, UKHealth Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK9 Bristol Medical School, University of Bristol, Bristol, UKUniversity of Edinburgh College of Medicine and Veterinary Medicine, Edinburgh, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKMolecular and Clinical Sciences Research Institute, St George’s University of London, London, UKThe University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKCentre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UKCentre for Reproductive Health, The University of Edinburgh, Edinburgh, UKCEO, Parent Infant Foundation, London, UKCentre for Reproductive Health, The University of Edinburgh, Edinburgh, UKCentre for Reproductive Health, The University of Edinburgh, Edinburgh, UKResearch and Resources Officer, Twins Trust, London, UKIntroduction 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.https://bmjopen.bmj.com/content/14/1/e078778.full |
| spellingShingle | Jane E Norman John Norrie Jane Denton James P Boardman Kathleen Anne Boyd Manuela Deidda Karen Luyt Catriona Keerie Debra Bick Asma Khalil Sarah Jane Stock Rebecca Reynolds Jessica Thompson Keith Reed Sarah Murray Rosie C Townsend Natasha Fenwick Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol BMJ Open |
| title | Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol |
| title_full | Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol |
| title_fullStr | Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol |
| title_full_unstemmed | Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol |
| title_short | Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol |
| title_sort | randomised placebo controlled trial of antenatal corticosteroids for planned birth in twins stoppit 3 study protocol |
| url | https://bmjopen.bmj.com/content/14/1/e078778.full |
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