WILL (when to induce labour to limit risk in pregnancy hypertension): protocol for a multicentre randomised trial
WILL (when to induce labour to limit risk in pregnancy hypertension): protocol for a multicentre randomised trial
Objectives: to address optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. Study design: Pragmatic, non-masked randomised trial. Inclusion: maternal age ≥16 years, chronic or gestational hypertension, singleton pregnancy, live fetus, 36+0–37+6 weeks’ gestation, and able to give documented informed consent. Exclusion: contraindication to either trial arm (e.g., pre-eclampsia or another indication for birth at term), blood pressure (BP) ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated to require neonatal care unit admission, or participation in another timing of birth trial. Randomisation (1:1 ratio, minimised for key prognostic variables: site, hypertension type, and prior Caesarean) to ‘planned early term birth at 38+0-3 weeks’ or ‘usual care at term’ (revised from ‘expectant care until at least 40+0 weeks’, Aug 2022).
Outcomes: maternal co-primary: composite of ‘poor maternal outcome’ (severe hypertension, maternal death, or maternal morbidity). Neonatal co-primary: neonatal care unit admission for ≥4 h. Each co-primary is measured until primary hospital discharge or 28 days post-birth (whichever is earlier). Key secondary: Caesarean birth.
Analysis: sample of 1080 participants (540/arm) will detect an 8% reduction in the maternal co-primary (90% power, superiority hypothesis), and give 94% power for a between-group non-inferiority margin of difference of 9% in the neonatal co-primary. Analysis will be by intention-to-treat. Ethics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18/LO/2033). Conclusions: The study will provide data for women to make informed choices about their care and allow health systems to plan services.
Hypertension, Induction, Maternal outcomes, Perinatal outcomes, Pregnancy, Timing of birth, Blood Pressure, Hypertension, Pregnancy-Induced, Humans, Randomized Controlled Trials as Topic, Cesarean Section, Labor, Obstetric, Multicenter Studies as Topic, Adolescent, Pre-Eclampsia, Female, Infant, Newborn
35-42
Kirkham, Katie
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Tohill, Sue
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Hutcheon, Jennifer A.
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Dorling, Jon
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Gkini, Eleni
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Moakes, Catherine A.
eedafd90-5006-47ed-9c9a-0e33f2949e1e
Stubbs, Clive
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Thornton, Jim
ac3af3ba-9b2e-4291-98d5-3618a853123f
von Dadelszen, Peter
99289cc7-421a-405b-b2b7-9636ec4818e8
Magee, Laura A.
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the WILL Trial Study Group
June 2023
Kirkham, Katie
08d797cc-7844-49a6-9d7d-a92ebc7179cc
Tohill, Sue
a8ecd092-0392-4c0f-a460-0f28e2439f89
Hutcheon, Jennifer A.
3a181486-aa3e-4bb6-9071-483728457614
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Gkini, Eleni
0c6897c3-1aa2-4335-aa38-ef462dc9aedb
Moakes, Catherine A.
eedafd90-5006-47ed-9c9a-0e33f2949e1e
Stubbs, Clive
03d81c31-fd9f-407f-bec8-ebdc5821d2ec
Thornton, Jim
ac3af3ba-9b2e-4291-98d5-3618a853123f
von Dadelszen, Peter
99289cc7-421a-405b-b2b7-9636ec4818e8
Magee, Laura A.
12dc7d1f-b93a-421f-8f47-46e436e5cc30
Kirkham, Katie, Tohill, Sue, Hutcheon, Jennifer A., Dorling, Jon, Gkini, Eleni, Moakes, Catherine A., Stubbs, Clive, Thornton, Jim, von Dadelszen, Peter and Magee, Laura A.
,
the WILL Trial Study Group
(2023)
WILL (when to induce labour to limit risk in pregnancy hypertension): protocol for a multicentre randomised trial.
Pregnancy Hypertension, 32, .
(doi:10.1016/j.preghy.2023.03.002).
Abstract
Objectives: to address optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. Study design: Pragmatic, non-masked randomised trial. Inclusion: maternal age ≥16 years, chronic or gestational hypertension, singleton pregnancy, live fetus, 36+0–37+6 weeks’ gestation, and able to give documented informed consent. Exclusion: contraindication to either trial arm (e.g., pre-eclampsia or another indication for birth at term), blood pressure (BP) ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated to require neonatal care unit admission, or participation in another timing of birth trial. Randomisation (1:1 ratio, minimised for key prognostic variables: site, hypertension type, and prior Caesarean) to ‘planned early term birth at 38+0-3 weeks’ or ‘usual care at term’ (revised from ‘expectant care until at least 40+0 weeks’, Aug 2022).
Outcomes: maternal co-primary: composite of ‘poor maternal outcome’ (severe hypertension, maternal death, or maternal morbidity). Neonatal co-primary: neonatal care unit admission for ≥4 h. Each co-primary is measured until primary hospital discharge or 28 days post-birth (whichever is earlier). Key secondary: Caesarean birth.
Analysis: sample of 1080 participants (540/arm) will detect an 8% reduction in the maternal co-primary (90% power, superiority hypothesis), and give 94% power for a between-group non-inferiority margin of difference of 9% in the neonatal co-primary. Analysis will be by intention-to-treat. Ethics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18/LO/2033). Conclusions: The study will provide data for women to make informed choices about their care and allow health systems to plan services.
Text
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More information
Accepted/In Press date: 17 March 2023
e-pub ahead of print date: 3 April 2023
Published date: June 2023
Additional Information:
Funding Information: the trial is funded by the National Institute of Health Research (NIHR) Health Technology Assessment (project number 16/167/123). The co-sponsor is King’s College London and Guy’s and St Thomas’ NHS Foundation Trust. The trial is co-ordinated by the Birmingham Clinical Trials Unit. Neither the funder nor co-sponsor are (or will be) involved in data collection or analysis.
Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.
Keywords:
Hypertension, Induction, Maternal outcomes, Perinatal outcomes, Pregnancy, Timing of birth, Blood Pressure, Hypertension, Pregnancy-Induced, Humans, Randomized Controlled Trials as Topic, Cesarean Section, Labor, Obstetric, Multicenter Studies as Topic, Adolescent, Pre-Eclampsia, Female, Infant, Newborn
Identifiers
Local EPrints ID: 484956
URI: http://eprints.soton.ac.uk/id/eprint/484956
ISSN: 2210-7789
PURE UUID: 036d9162-9c52-4009-8889-8efab93fa9e8
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Date deposited: 27 Nov 2023 17:31
Last modified: 18 Mar 2024 04:16
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Contributors
Author:
Katie Kirkham
Author:
Sue Tohill
Author:
Jennifer A. Hutcheon
Author:
Jon Dorling
Author:
Eleni Gkini
Author:
Catherine A. Moakes
Author:
Clive Stubbs
Author:
Jim Thornton
Author:
Peter von Dadelszen
Author:
Laura A. Magee
Corporate Author: the WILL Trial Study Group
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