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: Martijn A Oudijk, Madelon van Wely, Eva Pajkrt, Job Klumper, Aleid G van Wassenaer-Leemhuis, Emilie V J van Limburg Stirum, Janneke Van 't Hooft, Larissa van der Windt
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMJ Open, Vol 14, Iss 7 (2024)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2023-083600
Popis: 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
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