Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation (Publication with Expression of Concern. See JAN, 2023)

Objective: To evaluate whether use of the Fetal Pillow (Safe Obstetric Systems, Shenfield, UK) affects maternal and fetal morbidity in cesarean delivery at full cervical dilatation. Methods: A randomized controlled trial was conducted at two teaching hospitals in West Bengal, India, between April 1, 2013, and March 31, 2014. Women undergoing cesarean delivery at full dilatation were enrolled and randomly assigned with computer generated random numbers (block size 10) to undergo delivery with or without the Fetal Pillow. Group assignment was not masked. The primary outcome was the incidence of major uterine wound extensions (grade 2-3). Results: Overall, 120 women were assigned to each group. Major uterine wound extensions occurred in 6 (5.0%) women in the Fetal Pillow group and 39 (32.5%) in the control group (relative risk 0.23, 95% confidence interval 0.11-0.48). Conclusion: Use of the Fetal Pillow in second-stage cesarean delivery significantly reduces the risk of a major extension of the uterine incision. (C) 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.