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September 10, 2026Maternal-Fetal MedicineOpen Access

Assessing the Uptake of the Core Outcome Set in Randomized Controlled Trial Registrations for the Treatment of Pre-eclampsia Before and After Its Publication

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Authors

KAKailibinuer AilimuZWZiyan WangWLWenqiang Li

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Overview

Cross-sectional registry study demonstrates modest uptake of core outcome sets in pre-eclampsia trial registrations, highlighting persistent gaps in neonatal endpoints and standardized definitions.

Key Points

  • To evaluate the uptake of the pre-eclampsia core outcome set in randomized controlled trial registrations before and after publication, and to identify factors associated with its implementation.
  • Screened randomized controlled trial registrations on pre-eclampsia treatment from the World Health Organization International Clinical Trials Registry Platform, including N = 279 eligible trials.
  • Extracted trial characteristics in duplicate and evaluated the consistency between registered outcome definitions and core recommendations.
  • Identified factors independently associated with core outcome set uptake using multivariable logistic and negative binomial regression models.
  • Post-publication registration was independently associated with a higher number of core outcomes reported per trial (adjusted RR: 1.53, 95% CI: 1.02–2.29, P = 0.039), but did not significantly increase the likelihood of reporting at least one core outcome (adjusted OR: 1.31, 95% CI: 0.73–2.35, P = 0.361).
  • Overall, 47.0% (n = 131/279) of trial registrations reported at least one specific core outcome, with maternal outcomes adopted more frequently (39.4%, n = 110) than neonatal outcomes (21.5%, n = 60).
  • Consistency between registered definitions and core recommendations ranged from 0% to 91.4%, with only two individual outcomes exceeding 50% alignment.

Cite This Study

Ailimu et al. (2026) studied this question.

synapsesocial.com/papers/6aa27bcf58559d80afc753e0https://doi.org/10.1097/fm9.0000000000000378
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