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Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.
BJOG. 2020 08; 127(9):1129-1137.BJOG

Abstract

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.

Authors+Show Affiliations

Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands.Paediatrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.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.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32124520

Citation

van Winden, Tms, et al. "Effects of Tocolysis With Nifedipine or Atosiban On Child Outcome: Follow-up of the APOSTEL III Trial." BJOG : an International Journal of Obstetrics and Gynaecology, vol. 127, no. 9, 2020, pp. 1129-1137.
van Winden T, Klumper J, Kleinrouweler CE, et al. Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. BJOG. 2020;127(9):1129-1137.
van Winden, T., Klumper, J., Kleinrouweler, C. E., Tichelaar, M. A., Naaktgeboren, C. A., Nijman, T. A., van Baar, A. L., van Wassenaer-Leemhuis, A. G., Roseboom, T. J., Van't Hooft, J., Roos, C., Mol, B. W., Pajkrt, E., & Oudijk, M. A. (2020). Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. BJOG : an International Journal of Obstetrics and Gynaecology, 127(9), 1129-1137. https://doi.org/10.1111/1471-0528.16186
van Winden T, et al. Effects of Tocolysis With Nifedipine or Atosiban On Child Outcome: Follow-up of the APOSTEL III Trial. BJOG. 2020;127(9):1129-1137. PubMed PMID: 32124520.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. AU - van Winden,Tms, AU - Klumper,J, AU - Kleinrouweler,C E, AU - Tichelaar,M A, AU - Naaktgeboren,C A, AU - Nijman,T A, AU - van Baar,A L, AU - van Wassenaer-Leemhuis,A G, AU - Roseboom,T J, AU - Van't Hooft,J, AU - Roos,C, AU - Mol,B W, AU - Pajkrt,E, AU - Oudijk,M A, Y1 - 2020/03/29/ PY - 2020/02/17/accepted PY - 2020/3/4/pubmed PY - 2020/10/27/medline PY - 2020/3/4/entrez KW - Atosiban KW - behaviour KW - child KW - development KW - executive function KW - follow-up KW - health KW - infant KW - neurodevelopment KW - nifedipine KW - preterm birth KW - preterm labour KW - tocolysis SP - 1129 EP - 1137 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 127 IS - 9 N2 - 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. SN - 1471-0528 UR - https://www.unboundmedicine.com/medline/citation/32124520/Effects_of_tocolysis_with_nifedipine_or_atosiban_on_child_outcome:_follow_up_of_the_APOSTEL_III_trial_ L2 - https://doi.org/10.1111/1471-0528.16186 DB - PRIME DP - Unbound Medicine ER -