Hand Forceps for Delivery of Floating Fetal Head at Cesarean Section: A Randomized Pilot Study [ID: 1375984]

INTRODUCTION: On occasion, obstetricians encounter difficulty delivering the floating fetal head at cesarean section; additional techniques may need to be employed beyond the traditional one-handed delivery technique. We propose a modified two-handed manual delivery method or “hand forceps,” with surgeon’s both hands shaped like a pair of forceps, as an alternative technique for fetal head delivery. The purpose of this study is to compare the efficacy and safety of two-handed technique by comparing with the traditional one-handed technique. METHODS: We conducted a randomized pilot study of women undergoing cesarean section (NCT04159857, ClinicalTrials.gov). Inclusion criteria included a singleton in cephalic presentation, at gestational age of 37 weeks or greater, with planned low transverse uterine incision, cervical dilation of 6 cm or lower and station less than −3. Patients were randomized to either the one-handed or two-handed delivery group. The primary outcome was “U-D interval,” defined as the time from entry of the hands into the uterus to the delivery of the fetal head. The secondary outcome was incidence of hysterotomy extension. Neonatal safety data were also collected. RESULTS: A total of 40 patients participated in the study; 16 randomized to the one-handed group, 19 randomized to the two-handed group, and 5 patients excluded because of protocol deviation. U-D interval (mean±SD) was significantly shorter in the two-handed group (6.0±7.4 seconds) than in the one-handed group (14.3±9.9 seconds), P<.001. There was no significant difference in incidence of hysterotomy extension, maternal and neonatal outcomes between the two groups. CONCLUSION: The two-handed method for fetal head delivery has a significantly decreased U-D interval compared to the one-handed method, without increasing the incidence of hysterotomy extension. A large-scale multicenter randomized controlled study is needed to further determine whether the “hand forceps” can be considered a safe alternative technique for delivery of the floating fetal head in cesarean sections.