Ethics/Education| Volume 31, ISSUE 2, P59-60, February 2021

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The challenges of randomised control trials in obstetrics and gynaecology

Published:January 05, 2021DOI:


      In this short article we explore some of the challenges faced by those conducting randomised trials in obstetrics and gynaecology. We discuss the current status of trials comparing induction of labour versus expectant management, so called ‘deliver or delay’ trials. We consider the benefits of utilising routine data for collecting trial outcome data. Although cluster trials can provide a useful methodology for answering difficult questions, we illustrate with an example that cluster trials are at risk of delivering a misleading result. We discuss the importance of long term outcomes in randomised trials.


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      Further reading

        • Duhig K.E.
        • Myers J.
        • Seed P.T.
        • et al.
        Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial.
        Lancet. 2019; 393: 1807-1818
        • Grobman W.A.
        Labor induction vs. Expectant management of low-risk pregnancy.
        N Engl J Med. 2018; 379: 2278-2279
        • Hemming K.
        • Haines T.P.
        • Chilton P.J.
        • Girling A.J.
        • Lilford R.J.
        The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting.
        BMJ. 2015; 350: h391
        • Norman J.E.
        • Heazell A.E.P.
        • Rodriguez A.
        • et al.
        Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial.
        Lancet. 2018; 392: 1629-1638
        • Tanner M.
        • Mol B.W.
        Placental growth factor testing in suspected pre-eclampsia.
        Lancet. 2020; 395: 335