An inflatable ergonomic 3-chamber fundal pressure belt to assist vaginal delivery.

Objective To evaluate whether Baby-guard—a new medical device with an ergonomic 3-chamber inflatable abdominal belt—can reduce complications associated with vaginal delivery. Methods A randomized controlled single-blind prospective study of 80 pregnant women delivering at term was conducted at San Giuseppe Hospital, Empoli, Italy. In the study group (n = 40), the abdominal belt was inflated to optimal therapeutic pressures. In the control group (n = 40), the abdominal belt was inflated to minimal, non-therapeutic pressures. Factors relating to maternal, fetal, and labor complications during vaginal delivery were evaluated. Results Compared with the control group, women in the study group experienced a lower incidence of perineal and cervical lacerations (P < 0.001); reduced use of the Kristeller maneuver (P < 0.001); shorter duration of the second stage of labor (P < 0.001); less psychologic and physical fatigue (P < 0.001); fewer maternal requests for cesarean delivery during labor (P < 0.001); fewer vacuum extractions (P < 0.01); and fewer cesarean deliveries (P < 0.02). No neonatal intensive care unit admissions were recorded in the study group versus 7 in the control group (P < 0.012). Conclusion Use of the ergonomic 3-chamber inflatable abdominal belt system reduced the incidence of risks associated with vaginal labor. Clinical trials.gov identifier: NCT01566331.