Abstract
Objective
The APOSTEL-III study was a multicenter RCT that compared atosiban and nifedipine in women with threatened preterm birth (Van Vliet et al, Lancet 2016). The primary outcome, a composite of neonatal short term morbidity and mortality was comparable between the two arms.
We sought to compare the long-term effects of tocolysis with atosiban or nifedipine on health and development of children.
Study Design
The APOSTEL III study randomized 505 women in 19 Dutch and Belgian hospitals. Five years later, we asked all participants to complete four questionnaires.
Main outcome measures were neurological and behavioral development at the age of 2.5-5.5 years. The three developmental questionnaires are divided in subscales that cover a specific domain of child development, expressed in scores standardized for age and sex. The children in the atosiban and nifedipine groups were compared by calculating T-scores, thus identifying infants with substandard scores. Additionally, a questionnaire regarding general health was used. Exclusion criteria were: infants older than 66 months, no surviving infant, participant not traceable or refusal of participance.
Results
Of the 370 women eligible for follow up, 194 (52%) women returned the questionnaires, encompassing data of 108 infants to atosiban and 114 infants randomized to nifedipine. Baseline characteristics did not differ between both groups with respect to responders vs non-responders as well as within the treatment arms in the responding group. Developmental outcome as measured by the ASQ-3, BRIEF-P, CBCL and general health questionnaires, is shown in Table 1. Overall, there were no significant differences between the groups.
Total developmental delay did not differ between the atosiban and nifedipine and group (34.3 % vs 28.9 %, OR 1.28; 95% CI 0.73-2.26). However, a difference was found in the subdomain problem solving (21.3 % vs 9.6%, OR 2.53; 95% CI 1.17-5.49). We performed a sensitivity analysis by including neonatal deaths, all scoring substandard. This showed no group difference in substandard scores (26.1 % vs 20.8%, OR 1.35; 95% CI 0.74-2.44).
Executive function disorders were similar (12.0 vs 11.4%, OR 1.06; 95% CI 0.47-2.41) as well as behavioral problems (6.5% vs 8.8%, OR 0.72; 95% CI 0.26-1.97). No differences in general health were found.
Conclusion
In this long-term follow-up study of tocolysis, outcomes on broad child development and behavior were not different between atosiban and nifedipine exposed children.
The APOSTEL-III study was a multicenter RCT that compared atosiban and nifedipine in women with threatened preterm birth (Van Vliet et al, Lancet 2016). The primary outcome, a composite of neonatal short term morbidity and mortality was comparable between the two arms.
We sought to compare the long-term effects of tocolysis with atosiban or nifedipine on health and development of children.
Study Design
The APOSTEL III study randomized 505 women in 19 Dutch and Belgian hospitals. Five years later, we asked all participants to complete four questionnaires.
Main outcome measures were neurological and behavioral development at the age of 2.5-5.5 years. The three developmental questionnaires are divided in subscales that cover a specific domain of child development, expressed in scores standardized for age and sex. The children in the atosiban and nifedipine groups were compared by calculating T-scores, thus identifying infants with substandard scores. Additionally, a questionnaire regarding general health was used. Exclusion criteria were: infants older than 66 months, no surviving infant, participant not traceable or refusal of participance.
Results
Of the 370 women eligible for follow up, 194 (52%) women returned the questionnaires, encompassing data of 108 infants to atosiban and 114 infants randomized to nifedipine. Baseline characteristics did not differ between both groups with respect to responders vs non-responders as well as within the treatment arms in the responding group. Developmental outcome as measured by the ASQ-3, BRIEF-P, CBCL and general health questionnaires, is shown in Table 1. Overall, there were no significant differences between the groups.
Total developmental delay did not differ between the atosiban and nifedipine and group (34.3 % vs 28.9 %, OR 1.28; 95% CI 0.73-2.26). However, a difference was found in the subdomain problem solving (21.3 % vs 9.6%, OR 2.53; 95% CI 1.17-5.49). We performed a sensitivity analysis by including neonatal deaths, all scoring substandard. This showed no group difference in substandard scores (26.1 % vs 20.8%, OR 1.35; 95% CI 0.74-2.44).
Executive function disorders were similar (12.0 vs 11.4%, OR 1.06; 95% CI 0.47-2.41) as well as behavioral problems (6.5% vs 8.8%, OR 0.72; 95% CI 0.26-1.97). No differences in general health were found.
Conclusion
In this long-term follow-up study of tocolysis, outcomes on broad child development and behavior were not different between atosiban and nifedipine exposed children.
| Original language | English |
|---|---|
| Pages (from-to) | S199-S199 |
| Journal | American Journal of Obstetrics and Gynecology |
| Volume | 220 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 2019 |