1.1
More research is needed on balloon disimpaction of the baby's head at emergency caesarean during the second stage of labour before it can be used in the NHS.
1 Recommendations
1.2
This procedure should only be done as part of a formal research study, and a research ethics committee needs to have approved its use.
1.3
The procedure should only be done by staff trained in managing an emergency caesarean birth when the baby's head is impacted.
1.4
Centres already using this procedure may continue to do so but are encouraged to collect data or do further research on the outcomes listed in recommendation 1.5.
What research is needed
1.5
More research, including randomised controlled trials or a registry, is needed on:
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how the procedure compares with other options
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patient selection, such as the characteristics of the woman, trans man or non-binary person giving birth, and risk factors
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longer-term (beyond the immediate postpartum period and after hospital discharge) safety and efficacy outcomes for the woman, trans man or non-binary person giving birth, and the baby.
Why the committee made these recommendations
Several publications that provided supporting evidence for NICE's interventional procedures guidance on balloon disimpaction of the baby's head at emergency caesarean during the second stage of labour have been retracted since the guidance was published. This includes a key study that was retracted because the journal's research integrity team found several inconsistencies in the results presented. There is now a lack of high-quality evidence to show whether the procedure improves outcomes for either the woman, trans man or non-binary person giving birth, or the baby. But there are no major safety concerns. So, this procedure can be used in research.