Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.

Autor: van Winden T; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Klumper J; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Kleinrouweler CE; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Tichelaar MA; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Naaktgeboren CA; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands., Nijman TA; Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands., van Baar AL; Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands., van Wassenaer-Leemhuis AG; Paediatrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Roseboom TJ; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.; Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Van't Hooft J; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Roos C; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Mol BW; Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia., Pajkrt E; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Oudijk MA; Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2020 Aug; Vol. 127 (9), pp. 1129-1137. Date of Electronic Publication: 2020 Mar 29.
DOI: 10.1111/1471-0528.16186
Abstrakt: Objective: To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.
Design: The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.
Methods: Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health.
Main Outcome Measures: The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.
Results: Of the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.
Conclusion: Outcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.
Tweetable Abstract: Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function and behaviour.
(© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)
Databáze: MEDLINE
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