An inflatable ergonomic 3‐chamber fundal pressure belt to assist vaginal delivery. Issue 1 (16th October 2012)

• Record Type: Journal Article
• Authors: Acanfora, Luisa; Rampon, Michela; Filippeschi, Marco; Marchi, Marco; Montisci, Massimo; Viel, Guido; Cosmi, Erich
• Is Part Of: International journal of gynaecology and obstetrics. Volume 120:Issue 1(2013)
• Page Start: 78
• Page End: 81
• Publication Date: 2012-10-16
• Subjects: Complication -- Labor -- Outcome -- Safety -- Uterine fundal pressure -- Vaginal delivery; Gynecology -- Periodicals; Obstetrics -- Periodicals; Electronic journals; 618
• DOI: 10.1016/j.ijgo.2012.07.025
• Languages: English
• ISSNs: 0020-7292

Abstract

Abstract: 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. Clinicaltrials.gov identifier: NCT01566331.