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

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. FUNDING: National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. TWEETABLE ABSTRACT: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.


Duffy, J. Hirsch, M. Pealing, L. Showell, M. Khan, K. S. Ziebland, S. McManus, R. J. International Collaboration to Harmonise Outcomes in, Pre-eclampsia


Journal: BJOG
Volume: 125
Issue: 7
Pages: 795 - 803
Year: 2018

Further Study Information

Current Stage: Not Applicable
Funding source(s):

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Pre-eclampsia

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- None

Study Type

- Systematic review of outcomes measured in trials


- Systematic review