We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safe Delivery Using a Belt on the Belly of Pregnant Woman (SDB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566331
First Posted: March 29, 2012
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Florence
Information provided by (Responsible Party):
Erich Cosmi MD, PhD, University of Padua
  Purpose

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.


Condition Intervention Phase
Other Obstetric Trauma - Delivered Device: Baby-guardTM Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Safe Natural Delivery by Using a New Inflatable Ergonomic Three Chambers Belt

Further study details as provided by Erich Cosmi MD, PhD, University of Padua:

Primary Outcome Measures:
  • Partecipant With Perineal Laceration [ Time Frame: after delivery ]
    The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)


Enrollment: 80
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Name: Safety baby guard
No Intervention: no intervention
Baby-guardTM system, without inflation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   23 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women in active labor at term in primipara with maternal age ranging from 23 to 42 years, with a singleton fetus in vertex presentation.
  • the onset of second stage was defined as full dilatation of the cervix identified by digital examination

Exclusion Criteria:

  • preterm labor (gestational age below 37 weeks)
  • breech or transverse presentation
  • suspected fetal macrosomia
  • gestational diabetes
  • pregnancy-induced hypertension
  • abnormalities of placentation (low lying placenta, abruptio placenta)
  • uterine structural abnormalities
  • history of previous uterine scar
  • fetal heart rate abnormalities at the time of enrollment (bradycardia, tachycardia or prolonged variable decelerations).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566331


Locations
Italy
University of Padua
Padua, Italy, 35128
Sponsors and Collaborators
University of Padua
University of Florence
Investigators
Study Chair: luisa Acanfora, MD University of Florence
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erich Cosmi MD, PhD, Director of Maternal and Fetal Medicine, Department of Woman and Child Health, University of Padua
ClinicalTrials.gov Identifier: NCT01566331     History of Changes
Other Study ID Numbers: unipd
First Submitted: March 19, 2012
First Posted: March 29, 2012
Results First Submitted: May 19, 2014
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Erich Cosmi MD, PhD, University of Padua:
Safe Delivery
reduction of pain
reduction stage of labor