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).


CONCLUSIONS
Use of the ergonomic 3-chamber inflatable abdominal belt system reduced the incidence of risks associated with vaginal labor. Clinical trials.gov identifier: NCT01566331.
Department of Physiology, University of Florence, Florence, Italy.
Luisa
L
Acanfora
Michela
M
Rampon
Marco
M
Filippeschi
Marco
M
Marchi
Massimo
M
Montisci
Guido
G
Viel
Erich
E
Cosmi
D000328:Adult; D002584:Cervix Uteri / Q000293:injuries*; D002585:Cesarean Section / Q000706:statistics & numerical data; D036861:Delivery, Obstetric / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D006804:Ergonomics; D005221:Fatigue / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007558:Italy; D007748:Labor Stage, Second; D022125:Lacerations / Q000453:epidemiology; D010502:Perineum / Q000293:injuries*; D011247:Pregnancy; D011312:Pressure; D011446:Prospective Studies; D016037:Single-Blind Method; D014620:Vacuum Extraction, Obstetrical / Q000706:statistics & numerical data