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

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.
 
ClinicalTrials.gov Identifier: NCT01566331
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Erich Cosmi MD, PhD, University of Padova

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Health Services Research
Condition Other Obstetric Trauma - Delivered
Intervention Device: Baby-guardTM
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baby-guardTM Baby-guardTM Minimal Inflation
Hide Arm/Group Description

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

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

Baby-guardTM with minimal inflation who expected natural delivery
Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Baby-guardTM Baby-guardTM With Minimal Inflation Total
Hide Arm/Group Description 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 Baby-guardTM system, with minimal inflation in women who expected natural delivery Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
40
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
30.97  (5.16) 31.45  (1.2) 31.1  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
40
 100.0%
40
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Partecipant With Perineal Laceration
Hide Description 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)
Time Frame after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
intervention in normal pregnancies at term during labor and delivery
Arm/Group Title Baby Belt Device Group Baby-guardTM With Minimal Inflation
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
3 31
Time Frame discomfort during labor
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baby Birth Baby Birth With Minimal Inflation
Hide Arm/Group Description group delivering with baby birth group delivering with dwvice and minimal inflation
All-Cause Mortality
Baby Birth Baby Birth With Minimal Inflation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Baby Birth Baby Birth With Minimal Inflation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Baby Birth Baby Birth With Minimal Inflation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Erich Cosmi
Organization: University of Padua
Phone: +393398146745
EMail: ecosmi@hotmail.com
Layout table for additonal information
Responsible Party: Erich Cosmi MD, PhD, University of Padova
ClinicalTrials.gov Identifier: NCT01566331    
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