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An inflatable ergonomic 3‐chamber fundal pressure belt to assist vaginal delivery
Author(s) -
Acanfora Luisa,
Rampon Michela,
Filippeschi Marco,
Marchi Marco,
Montisci Massimo,
Viel Guido,
Cosmi Erich
Publication year - 2013
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2012.07.025
Subject(s) - medicine , inflatable , randomized controlled trial , incidence (geometry) , prospective cohort study , vaginal delivery , surgery , obstetrics , pregnancy , gynecology , mechanical engineering , physics , genetics , engineering , biology , optics
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.