Interventional procedure overview of balloon disimpaction of the baby's head at emergency caesarean
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/ follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Hanley I, Sivanesan K, Veerasingham M et al. (2020) Comparison of outcomes at full-dilation cesarean section with and without the use of a fetal pillow device. International Journal of Gynecology and Obstetrics 150: 228–33 | Non-randomised comparative study n=174 patients | There were no statistically significant differences in operative complications between the pillow and no-pillow groups (odds ratio 0.56, 95% CI 0.26 to 1.22, p=0.146). Linear regression analysis showed a decrease in hospital length of stay (hours) (-9.4, 95% CI ‑17.80 to -0.99, p=0.029) and a higher neonatal arterial pH at delivery (0.06, 95% CI 0.03 to 0.09, p=0.0001) in the pillow group. | Non-randomised comparative study, which is included in the systematic review by Di Girolamo et al. (2021). |
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. A more recent systematic review is included. |
Sacre H, Bird A, Clement-Jones M et al. (2021) Effectiveness of the fetal pillow to prevent adverse maternal and fetal outcomes at full dilatation cesarean section in routine practice. Acta Obstetricia et Gynecologica Scandinavica 100: 949–54 | Non-randomised comparative study n=391 pregnancies | This is the largest study to date on the use of the fetal pillow at full dilatation caesarean section. It did not demonstrate any statistically significant benefit from the use of the fetal pillow to prevent any maternal or fetal adverse outcomes at full dilatation caesarean section in routine clinical use. Further randomised studies are needed to prove clinical benefit from this device before more widespread use. | Non-randomised comparative study, which is included in the systematic review by Di Girolamo et al. (2021). |
Safa H, Beckmann M (2016) Comparison of maternal and neonatal outcomes from full-dilatation cesarean deliveries using the Fetal Pillow or hand-push method. International Journal of Gynaecology and Obstetrics 135: 281–4 | Non-randomised comparative study n=160 pregnancies | Lower mean intra-operative blood loss (p=0.026), a shorter duration of postpartum hospital admission (p=0.002), and higher mean cord arterial pH (p=0.003) were observed in the Fetal Pillow group. | Non-randomised comparative study, which is included in the systematic review by Di Girolamo et al. (2021). |
Seal SL, Dey A, Barman SC et al. (2014) Does elevating the fetal head prior to delivery using a fetal pillow reduce maternal and fetal complications in a full dilatation caesarean section? A prospective study with historical controls. Journal of Obstetrics and Gynaecology 34: 241–4 | Non-randomised comparative study n=174 patients | Patients in the fetal pillow group had a lower incidence of extensions (p=0.03), shorter operating time (p<0.001), uterine incision to delivery interval (p<0.001) and shorter length of hospital stay (p<0.001). Blood loss >1,000 ml and admission to intensive care was also lower but were not statistically significant. There were no significant differences in the fetal complications studied, APGAR scores, admission to neonatal intensive care unit, seizures, neonatal injury or death. | Non-randomised comparative study, which is included in the systematic review by Di Girolamo et al. (2021). |
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