Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation

International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)

Research output: Contribution to journalReview articlepeer-review

23 Citations (Scopus)


Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. Objective: To assess safety reporting in pre-eclampsia trials. Search strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Selection criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Data collection and analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. Main results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating ‘safety and toleration’ and ‘possible side effects’ would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.

Original languageEnglish
Pages (from-to)795-803
Number of pages9
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Issue number7
Early online date19 Dec 2017
Publication statusPublished - Jun 2018
EventRoyal College of Obstetricians and Gynaecologists World Congress - Cape Town, South Africa
Duration: 20 Mar 201722 Mar 2017

Bibliographical note

This report is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Prof. Richard McManus is supported by a National Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care, Oxford. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Data Availability Statement

This paper includes Author Insights, a video abstract available at

Additional Supporting Information may be found in the online version of this article: Table S1.Included study characteristics. Table S2. Adverse reactions and laboratory defined toxicity reported in randomised trials evaluating magnesium sulphate. Appendix S1.EMBASE search strategy. Video S1.Author insights.


  • Adverse reactions
  • core outcome sets
  • outcome reporting bias
  • pre-eclampsia
  • systematic review


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