Atosiban versus placebo in the treatment of threatened preterm birth between 30 and 34 weeks gestation: study protocol of the 4-year APOSTEL 8 follow-up.

Autor:	van der Windt L; Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands l.i.vanderwindt@amsterdamumc.nl.; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands., Klumper J; Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands., van Limburg Stirum EVJ; Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands., van 't Hooft J; Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands., van Wely M; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands.; Netherlands Satellite of the Cochrane Gynaecology and Fertility Group, Amsterdam University Medical Centres, Duivendrecht, The Netherlands., van Wassenaer-Leemhuis AG; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands.; Department of Neonatology and Paediatrics, Emma Children's Hospital, Amsterdam UMC Location AMC, Amsterdam, The Netherlands., Pajkrt E; Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands., Oudijk MA; Amsterdam Reproduction and Development research institute, Amsterdam, Netherlands.; Obstetrics, Amsterdam UMC Locatie De Boelelaan, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jul 18; Vol. 14 (7), pp. e083600. Date of Electronic Publication: 2024 Jul 18.
DOI:	10.1136/bmjopen-2023-083600
Abstrakt:	Introduction: Currently, the majority of women worldwide with threatened preterm birth are treated with tocolytics. Although tocolytics can effectively delay birth for 48 hours, no tocolytic drug has convincingly been shown to improve neonatal outcomes and effects on long-term child development are unknown. The aim of this follow-up study of a placebo controlled randomised trial is to investigate the long-term effects of atosiban administration in case of threatened preterm birth on child's neurodevelopment and behaviour development, overall health and mortality. Methods and Analysis: This protocol concerns a follow-up study of the multicentre randomised double-blind placebo controlled APOSTEL 8 trial (NL61439.018.17, EudraCT-number 2017-001007-72). In this trial, women with threatened preterm birth (between 30 and 34 weeks of gestation) defined as uterine contractions with (1) a cervical length of <15 mm or (2) a cervical length of 15-30 mm and a positive fibronectin test or (3) in centres where cervical length measurement is not part of the local protocol: a positive fibronectin test or Actim-Partus test or (4) ruptured membranes, are randomised to atosiban or placebo for 48 hours. The primary outcome is a composite of perinatal mortality and severe neonatal morbidity. Children born to mothers who participated in the APOSTEL 8 study (n=760) will be eligible for follow-up at 4 years of corrected age and assessed using four parent-reported questionnaires. Primary outcomes are neurodevelopment and behaviour problems. Secondary outcomes are on child growth and general health. All outcomes will be compared between the atosiban and placebo group with OR and corresponding 95% CI. Analyses will be performed using the intention-to-treat approach. Ethics and Dissemination: The Medical Research Ethics Committee from Amsterdam UMC confirmed that de Medical Research Involving Human Subjects Act (Dutch WMO-law) did not apply to our study (W21_386 # 21.431). Results will be published in a peer-reviewed journal and shared with stakeholders and participants. This protocol is published before analysis of the results. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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