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Published on: January 12, 2018
Long-term child follow-up after randomised controlled trials evaluating prevention of preterm birth interventions: A
Larissa I van der Windt1, Noor E Simons1, Annemijn A de Ruigh1
1Department of Obstetrics and Gynaecology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands.
Insights
Few randomized controlled trials (RCTs) evaluating preterm birth prevention include long-term child development outcomes. However, long-term follow-up significantly altered conclusions in over a third of studies, highlighting the need for standard practice.
Area of Science:
- Obstetrics and Gynecology
- Developmental Pediatrics
- Clinical Trial Methodology
Background:
- Obstetric interventions for preterm birth prevention may have unforeseen long-term effects on child development.
- Current research often lacks standard evaluation of these long-term developmental outcomes.
Approach:
- A systematic literature search was conducted across MEDLINE, Embase, and Cochrane Central Library for randomized controlled trials (RCTs) focused on preterm birth prevention in asymptomatic pregnancies.
- Web of Science was used to identify publications reporting long-term child outcomes stemming from these RCTs.
- Studies were included if they assessed child outcomes after hospital discharge, defining them as long-term follow-up.
Key Points:
- Out of 188 RCTs on preterm birth prevention, only 15 (8.0%) included long-term child outcome assessments.
- Neurodevelopment was the primary focus in 76.5% of follow-up studies, utilizing various standardized tools.
- Long-term follow-up data led to a change in the overall conclusions of the original RCTs in 42.9% of cases.
Conclusions:
- A small proportion of RCTs investigating preterm birth prevention interventions incorporate long-term child development assessments.
- Despite the low frequency, long-term follow-up data altered study conclusions in a significant number of cases (approximately one-third).
- Implementing routine long-term follow-up studies is crucial for accurately informing parents about potential childhood effects of interventions.
Background:
Obstetric interventions can have unexpected long-term effects on child development. However, evaluation of these outcomes is not standard in current research.
Objectives:
To give an overview of long-term follow-up studies after randomised controlled trials (RCTs) evaluating interventions to prevent preterm birth in asymptomatic pregnancies.
Search Strategy:
Databases MEDLINE, Embase and Cochrane Central Library were searched for relevant RCTs. WebofScience was crosschecked for citations of these RCTs for publications on long-term child outcomes.
Selection Criteria:
RCTs evaluating interventions to prevent preterm birth in asymptomatic pregnant women. A long-term follow-up study was defined as such when child outcomes were assessed after discharge from hospital after birth.
Data Collection And Analysis:
Proportion of RCTs with long-term child follow-up was calculated with 95% confidence intervals (CI). Data on child's age at follow-up, outcome domains evaluated and measurement instruments were extracted.
Main Results:
We included 188 RCTs that evaluated interventions to prevent preterm birth. Only 15 of these RCTs assessed long-term child outcomes (8.0%; 95% CI 4.5 to 12.8) with 17 publications (two RCTs performed two follow-up studies). In 13 out of 17 (76.5%) follow-up publications, neurodevelopment was the primary outcome domain studied for which seven different standardized measurement tools were used. In total, 14 different standardized measurement tools were used to assess long-term outcomes. Overall conclusion regarding the effectiveness of the intervention changed in six studies (6/14 studies; 42.9%) based on long-term follow-up findings compared to the original RCT.
Conclusion:
Only a minority of the RCTs evaluating prevention of preterm birth interventions performed a long-term follow-up study to assess long-term outcomes on child development. However, the overall conclusions changed in one third of cases. Performance of follow-up studies should be standard in this population in order to counsel parents on potential childhood effects.
Funding:
Amsterdam Reproduction and Development.
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