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Safe Delivery Using a Belt on the Belly of Pregnant Woman

NCT01566331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-12-12

Study results available
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Summary

Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important goal among obstetricians, midwifes, scientific society all over the world. Maternal and newborn clinical problems and complications following vaginal delivery cause a big amount of medico-legal problems and high costs in the sanitary field.

Among the maneuvers that are used in the second stage of labor, uterine fundal pressure is one of the most controversial and often diffuse in all over the world, generally not documented, or under reported in medical records . Many Authors affirms that a different new way to push may be of help. This maneuver was introduced by Kristeller, that in 1867 minutely described a procedure to shorten, through the application of a pressure on the uterine fundus whose intensity was quantified by a dynamometer and the duration measured in seconds, the length of the second phase of the labor. Although uterine fundal pressure maneuver was described by Kristeller as the placement of two hands on the uterine fundus and the consequential application of longitudinal steady pressure at a 30- to 45-degree angle directed toward the pelvis, with the avoidance of direct pressure toward the maternal spine, there is no clear definition of the maneuver and no indication for its use has been formally described to date.

The aim of this study was therefore to assess whether the use of the Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes.

Conditions

  • Other Obstetric Trauma - Delivered

Interventions

DEVICE

Baby-guardTM

Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • University of Padova

    lead OTHER

Principal Investigators

  • luisa Acanfora, MD · University of Florence

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566331 on ClinicalTrials.gov