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    3 Committee considerations

    The evidence

    3.1

    NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 5 retrospective cohort studies, 2 randomised controlled trials, 1 prospective non-randomised comparative study and 2 case reports. Both the randomised controlled trials and all the cohort studies except 1 were also included in the systematic review. The evidence is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

    3.2

    The professional experts and the committee considered the key efficacy outcomes to be:

    • outcomes for the woman, trans man or non-binary person giving birth:

      • reduced time from the decision to have a caesarean to birth

      • reduced time from uterine incision to birth

      • reduced need for extension of uterine incision

      • less blood loss

      • fewer operative complications

    • outcomes for the baby:

      • improved Apgar scores

      • improved umbilical artery pH

      • less sepsis

      • reduced need for admission to a special care baby unit or newborn intensive care unit

      • less need for intubation

      • fewer deaths.

    3.3

    The professional experts and the committee considered the key safety outcomes to be trauma to the vagina or baby's head, and infection.

    3.4

    A submission was received from a patient organisation, which was considered by the committee. This highlighted the potentially severe and long-lasting effects of having a caesarean when the baby's head is impacted. They noted that the few women who had experience of balloon disimpaction of the baby's head were positive about it and had successful outcomes.

    Committee comments

    3.5

    The committee was told about a new programme funded by the Department of Health and Social Care called Avoiding Brain Injury in Childbirth (ABC). The aim of the programme is to improve outcomes for women, trans men or non-binary people giving birth, and their babies by implementing national clinical protocols, tools and multiprofessional training. This will include training on how to manage impaction of the baby's head during a caesarean birth.

    3.6

    The committee noted that some of the evidence described the balloon disimpaction device being used at a caesarean during the second stage of labour but not necessarily when there was impaction of the baby's head.

    3.7

    The committee was told that the balloon disimpaction device may be useful for less experienced staff.

    Tom Clutton-Brock

    Chair, interventional procedures advisory committee
    November 2024

    ISBN: