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

Objective To investigate associations of the Fetal Pillow® with maternal and neonatal morbidity. Design Retrospective cohort. Setting Two tertiary maternity units, New Zealand. Population or Sample Full 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. Methods Cases 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 Measures Primary outcome “any” uterine incision extension; secondary outcomes included major extension (into adjacent structures), and a composite neonatal outcome. Results In 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. Conclusions Despite 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.