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.
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.
Original language | English |
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Pages (from-to) | 1129-1137 |
Journal | BJOG: An International Journal of Obstetrics and Gynaecology |
Volume | 127 |
Issue number | 9 |
DOIs | |
Publication status | Published - Aug 2020 |
Keywords
- Atosiban
- behaviour
- child
- development
- executivefunction
- follow-up
- health
- infant
- neurodevelopment
- nifedipine
- preterm birth
- preterm labour
- tocolysis