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

Int J Gynaecol Obstet. 2013 Jan;120(1):78-81. doi: 10.1016/j.ijgo.2012.07.025. Epub 2012 Oct 16.


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 identifier: NCT01566331.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cervix Uteri / injuries*
  • Cesarean Section / statistics & numerical data
  • Delivery, Obstetric / instrumentation
  • Delivery, Obstetric / methods*
  • Equipment Design
  • Ergonomics
  • Fatigue / epidemiology*
  • Female
  • Humans
  • Incidence
  • Infant, Newborn
  • Italy
  • Labor Stage, Second
  • Lacerations / epidemiology
  • Perineum / injuries*
  • Pregnancy
  • Pressure
  • Prospective Studies
  • Single-Blind Method
  • Vacuum Extraction, Obstetrical / statistics & numerical data

Associated data