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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • The evidence included patients from centres in the UK, US, Australia and India.

    • A recent systematic review was identified, which included 2 randomised controlled trials, 4 prospective and 4 retrospective observational studies. One additional small randomised controlled trial was identified, which compared balloon disimpaction with reverse breech extraction.

    • One small randomised controlled trial, included in the systematic review, compared an inflated device with an uninflated device. The primary outcome for this trial was the time between hysterotomy and delivery, and it was underpowered to detect significant differences in other outcomes.

    • The authors of the systematic review noted there was heterogeneity in outcome assessment and definition and lack of stratification according to fetal head station.

    • The primary outcomes differed among the studies.