Interventional procedure overview of balloon disimpaction of the baby's head at emergency caesarean during the second stage of labour
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Appendix B: Other relevant studies
Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.
Study | Number of people and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Cornthwaite K, Hewitt P, Van Der Scheer JW et al. (2024) Definition, management, and training in impacted fetal head at cesarean birth: a national survey of maternity professionals. Obstetrical and Gynecological Survey 79: 135–37 | Survey of 419 maternity professionals in the UK | More than 70% found that a change of operator, manual cephalic extraction, tocolysis, operating changing hand, reserve breech extraction, Fetal Pillow, head-down tilt, and vaginal disimpaction were safe and effective techniques and adjunctive measures for managing impacted fetal head at caesarean delivery. The use of Fetal Pillow was positively accepted by 71 participants. | Survey of the management of impacted fetal head at caesarean birth in UK. |
Cornthwaite KR, Bahl R, Lattey K et al. (2024) Management of impacted fetal head at cesarean delivery. American Journal of Obstetrics and Gynecology 230: 980–87 | Expert review | There is currently no consensus on how best to manage impacted fetal head at caesarean delivery, resulting in a lack of confidence among maternity staff, variable practice, and potentially avoidable harm in some circumstances. Evidence for improved outcomes with balloon disimpaction is conflicting and no published study reported the decision to-delivery interval. Well-designed randomised controlled trials, in which the inclusion criteria are clearly defined and clinicians are appropriately trained, are urgently required to further investigate the management of impacted fetal head at caesarean delivery. | Review of overall management of impacted fetal head at caesarean delivery. |
Di Girolamo R, Galliani C, Buca D et al. (2021) Outcomes of second stage cesarean section following the use of a fetal head elevation device: A systematic review and meta-analysis. European Journal of Obstetrics, Gynecology, and Reproductive Biology 262: 1–6 | Systematic review n=1,326 (10 studies) | Application of a fetal head elevation device at full dilatation caesarean section seems to be associated with improvement in some maternal and neonatal outcomes. | One of the included randomised controlled trials has been retracted since the review was published. A more recent systematic review is included, which excludes the retracted trial. |
Jeve YB, Navti OB, Konje JC (2016) Comparison of techniques used to deliver a deeply impacted fetal head at full dilation: a systematic review and meta-analysis. BJOG 123: 337–45 | Systematic review n=12 studies | Meta-analysis showed that the risks of uterine incision extension, infection, mean blood loss, and operative time were statistically significantly higher with the push technique compared with the reverse breech extraction. The evidence to support the Patwardhan method and fetal pillow was inadequate. | Review included only 1 study on balloon disimpaction, which has been retracted. A more recent systematic review is included. |
Sadler L, Cronin R, Browne E et al. (2024) Obstetrician views on Fetal Pillow device use and research in Aotearoa New Zealand: A cross-sectional survey. The Australian & New Zealand Journal of Obstetrics & Gynaecology doi.org/10.1111/ajo.13824 | Review | The Fetal Pillow is available in most maternity units in Aotearoa New Zealand. Most obstetric clinicians believe it reduces maternal morbidity, while acknowledging the lack of scientific evidence. Most would support a randomised trial. | Survey of obstetrician views on balloon disimpaction device. |
Walker KF, Mitchell EJ, Ayers S, J et al. (2023) Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study. Health Technol Assess 27(6) | Scoping study | A trial was proposed to compare the fetal pillow with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. To be powered to test an effect on important short term maternal and baby outcomes it would need 754 participants per group. This would be feasible within the UK. | Study assessing the feasibility of a trial. |
Wyn Jones N, Mitchell EJ, Wakefield N et al. (2022) Impacted fetal head during second stage Caesarean birth: A prospective observational study. European Journal of Obstetrics, Gynecology, and Reproductive Biology 272: 77–81 | Prospective observational study n=3,518 second stage caesareans (564 with disimpaction technique) | The most common disimpaction techniques used were manual elevation of the head by an assistant through the vagina (n=235) and a fetal "pillow" (n=176). Thirteen babies (2%) died or sustained severe injury. Four babies died (2 directly attributable to the impacted fetal head). Fetal pillow was the most popular preventative strategy. Some units reported mandating use of the pillow in all caesareans following unsuccessful instrumental birth. The pillow was also used as treatment but less commonly than the push technique. | Survey of obstetricians practice in the UK. |
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