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 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

doi:10.1136/bmjopen-2023-078778

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 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 journal › Article › peer-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 language	English
Pages (from-to)	1-6
Journal	BMJ Open
Volume	14
DOIs	https://doi.org/10.1136/bmjopen-2023-078778
Publication status	Published - 18 Jan 2024

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A randomised Placebo-Controlled Trial of Antenatal Corticosteriods for Planned Birth in Twins: STOPPIT-3
Murray, S. & Stock, S.
Other
1/04/21 → 31/03/25
Project: Research

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Murray, S. R., Thompson, J., Townsend, R. C., Deidda, M., Boyd, K. A., Norman, J., Norrie, J., Boardman, J. P., Luyt, K., Khalil, A., Bick, D., Reed, K., Denton, J., Fenwick, N., Keerie, C., Reynolds, R., & Stock, S. J. (2024). Study protocol: a randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3). BMJ Open, 14, 1-6. https://doi.org/10.1136/bmjopen-2023-078778

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

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{\textquoteright} 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{\textquoteright}s Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo.",

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

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Murray, SR, Thompson, J, Townsend, RC, Deidda, M, Boyd, KA, Norman, J, Norrie, J, Boardman, JP, Luyt, K, Khalil, A, Bick, D, Reed, K, Denton, J, Fenwick, N, Keerie, C , Reynolds, R & Stock, SJ 2024, 'Study protocol: a randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3)', BMJ Open, vol. 14, pp. 1-6. https://doi.org/10.1136/bmjopen-2023-078778

TY - JOUR

T1 - Study protocol: a randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3)

AU - Murray, Sarah Rose

AU - Thompson, Jessica

AU - Townsend, Rosie C

AU - Deidda, Manuela

AU - Boyd, Kathleen Anne

AU - Norman, Jane

AU - Norrie, John

AU - Boardman, James P

AU - Luyt, Karen

AU - Khalil, Asma

AU - Bick, Debra

AU - Reed, Keith

AU - Denton, Jane

AU - Fenwick, Natasha

AU - Keerie, Catriona

AU - Reynolds, Rebecca

AU - Stock, Sarah Jane

PY - 2024/1/18

Y1 - 2024/1/18

N2 - 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.

AB - 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.

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DO - 10.1136/bmjopen-2023-078778

M3 - Article

SN - 2044-6055

VL - 14

SP - 1

EP - 6

JO - BMJ Open

JF - BMJ Open

ER -

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

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A randomised Placebo-Controlled Trial of Antenatal Corticosteriods for Planned Birth in Twins: STOPPIT-3

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