Volume 120, Issue 1 p. 78-81
Clinical articles

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

Luisa Acanfora

Luisa Acanfora

Department of Physiology, University of Florence, Florence, Italy

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Michela Rampon

Michela Rampon

Department of Woman and Child Health, Maternal and Fetal Medicine Unit, University of Padua, Padua, Italy

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Marco Filippeschi

Marco Filippeschi

Obstetrics and Gynecology Unit, San Giuseppe Hospital, Empoli, Italy

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Marco Marchi

Marco Marchi

Department of Statistics, University of Florence, Florence, Italy

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Massimo Montisci

Massimo Montisci

Department of Molecular Medicine, University of Padua, Padua, Italy

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Guido Viel

Guido Viel

Department of Molecular Medicine, University of Padua, Padua, Italy

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Erich Cosmi

Corresponding Author

Erich Cosmi

Department of Woman and Child Health, Maternal and Fetal Medicine Unit, University of Padua, Padua, Italy

Corresponding author at: Department of Woman and Child Health, Maternal and Fetal Medicine Unit, University of Padua, Via Giustiniani No 3, 35128, Padua, Italy. Tel.: + 39 339 8146745; fax: + 39 049 8211842.Search for more papers by this author
First published: 16 October 2012
Citations: 8

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.

Clinical trials.gov identifier: NCT01566331.