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Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
Summary
Most pre-eclampsia trials lack reporting on key maternal and offspring outcomes. Implementing a core outcome set is crucial for future research to reduce waste and improve data collection.
Area of Science:
- Obstetrics and Gynecology
- Perinatal Medicine
- Clinical Trial Methodology
Background:
- Standardizing outcome collection and reporting in pre-eclampsia research is essential.
- Current reporting practices in pre-eclampsia trials require critical appraisal.
Purpose of the Study:
- To systematically map and categorize maternal and offspring outcome reporting.
- To evaluate therapeutic interventions for pre-eclampsia in randomized trials.
Main Methods:
- Systematic search of bibliographical databases from inception to January 2016.
- Inclusion of randomized controlled trials evaluating pre-eclampsia interventions.
- Extraction and categorization of reported outcomes for maternal and offspring participants.
Main Results:
- 79 randomized trials (31,615 mothers, 28,172 offspring) evaluated 55 interventions.
- 119 distinct outcomes reported; maternal outcomes (72) and offspring outcomes (47) were inconsistently reported.
- Poor reporting of childhood outcomes (e.g., neurodevelopmental) and harms for both mothers and offspring.
Conclusions:
- Most trials investigating pre-eclampsia interventions omit crucial outcome data, especially for offspring efficacy and safety.
- A standardized core outcome set is needed for future pre-eclampsia trials to improve data quality and reduce research waste.
- Implementing a core outcome set can enhance the evaluation of interventions and ensure comprehensive data collection.
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