WILL (When to induce labour to limit risk in pregnancy hypertension): Protocol for a multicentre randomised trial.

Autor: Kirkham K; Birmingham Clinical Trials Unit, University of Birmingham, UK., Tohill S; Maternity Services, Guy's and St Thomas' NHS Foundation Trust, London, UK., Hutcheon JA; Department of Obstetrics and Gynaecology, University of British Columbia, Canada., Dorling J; Department of Paediatrics, University of Southampton, UK., Gkini E; Birmingham Clinical Trials Unit, University of Birmingham, UK., Moakes CA; Birmingham Clinical Trials Unit, University of Birmingham, UK., Stubbs C; Birmingham Clinical Trials Unit, University of Birmingham, UK., Thornton J; Department of Obstetrics and Gynaecology, University of Nottingham, UK., von Dadelszen P; Institute of Women and Children's Health, King's College London, UK; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK., Magee LA; Institute of Women and Children's Health, King's College London, UK; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: laura.a.magee@kcl.ac.uk.
Jazyk: angličtina
Zdroj: Pregnancy hypertension [Pregnancy Hypertens] 2023 Jun; Vol. 32, pp. 35-42. Date of Electronic Publication: 2023 Apr 03.
DOI: 10.1016/j.preghy.2023.03.002
Abstrakt: 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.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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