Maternal and neonatal morbidity associated with Fetal Pillow® use at full dilatation caesarean: A retrospective cohort

Abstract

ObjectiveTo investigate associations of the Fetal Pillow® with maternal and neonatal morbidity.DesignRetrospective cohort.SettingTwo tertiary maternity units, New Zealand.Population or SampleFull dilatation singleton, term, cephalic caesarean section, with three comparisons: at Unit A (1) before versus after introduction of the Fetal Pillow® (1 Jaunary 2016–31 October 2021); (2) with versus without the Fetal Pillow® after introduction (27 July 2017–31 October 2021); and (3) between Unit A and Unit B during the same time period (1 January 2019–31 October 2021). The Fetal Pillow® is unavailable at Unit B.MethodsCases were ascertained and clinical data were extracted from electronic clinical databases and records. Outcome data were adjusted and presented as adjusted odds ratios (aOR) with 95% CI.Main Outcome MeasuresPrimary outcome “any” uterine incision extension; secondary outcomes included major extension (into adjacent structures), and a composite neonatal outcome.ResultsIn all, 1703 caesareans were included; 375 with the device and 1328 without. Uterine incision extension rates were: at Unit A before versus after introduction: 26.8% versus 24.8% (aOR 0.88, 95% CI 0.65–1.19); at Unit A with the Fetal Pillow® versus without: 26.1% versus 23.8% (aOR 1.14, 95% CI 0.83–1.57); and at Unit A versus Unit B: 24.2% versus 29.2% (aOR 0.73, 95% CI 0.54–0.99). No differences were found in major extensions, or neonatal composite outcome.ConclusionsDespite the relatively large size of this study, it could not rule out either a positive or a negative association between use of the Fetal Pillow® and uterine extensions, major uterine incision extensions, and neonatal morbidity. Randomised controlled trial evidence is required to assess efficacy.