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Completeness of offspring outcome reporting across seventy-nine randomised trials, 31,615 participants, evaluating therapeutic interventions for pre-eclampsia

Presented at the Neonatal Society 2016 Summer Meeting.

Duffy JMN, Gale C, Hirsch M, Kawsar A, Pealing L, Plana MN, Showell M, Williamson PR, Khan KS, Ziebland S, McManus RJ

1 Balliol College, University of Oxford
2 Academic Neonatal Medicine, Imperial College London
3 Women’s Health Research Unit, Queen Mary, University of London
4 Cochrane Gynaecology and Fertility Group, University of Auckland
5 Institute of Translational Medicine, University of Liverpool
6 Ramon y Cajal Institute of Research, Madrid

Background: While much attention has been paid to standardising randomised controlled trial methods, the collection and reporting of outcomes in randomised trials has been largely overlooked. Objective: To map the availability of fetal, neonatal, and childhood outcomes and outcome measures across randomised trials evaluating therapeutic interventions for pre-eclampsia.

Methods: Design: Systematic review of randomised trials. Data sources: Randomised controlled trials identified by searching: [1] Cochrane Central Register of Controlled Trials, [2] MEDLINE, and [3] EMBASE from the inception of the database to January 2016. Study selection and methods:All randomised trials evaluating any therapeutic intervention for pre-eclampsia were included. We systematically extracted and organised outcomes reported in included trials. Funding sources:NIHR Doctoral Fellowship and MRC Clinician Scientist Fellowship.

Results: Seventy-nine randomised trials, including data from 31,615 maternal and 28,172 offspring participants, were included. Only 28 trials, included data from 25,839 offspring participants, reported offspring mortality. Forty-three trials, including data from 23,848 offspring participants, reported fetal outcomes, and 23 trials, including data from 24,227 offspring participants, reported neonatal outcomes. When considering the largest 25 included trials, intraventricular haemorrhage was reported by six trials, bronchopulmonary dysplasia was reported by two trials, and necrotising enterocolitis by five trials. There was poor reporting of childhood outcomes, only six trials, included data from 9,152 offspring participants, reported neurodevelopment outcomes. Less than half of included trials reported any relevant information regarding harms for offspring participants.

Conclusion: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a clinically relevant minimum core data set, in future pre-eclampsia trials could help to address these issues.

Corresponding author: james.duffy@balliol.ox.ac.uk

Duffy JMN, van ‘t Hooft J, Gale C, et al. A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia. Preg Hyper 2016; 10.1016/j.preghy.2016.04.008.

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