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

This study has been completed.
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Erich Cosmi MD, PhD, University of Padua
ClinicalTrials.gov Identifier:
NCT01566331
First received: March 19, 2012
Last updated: October 17, 2016
Last verified: October 2016
Results First Received: May 19, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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: 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 Minimal Inflation Baby-guardTM with minimal inflation who expected natural delivery

Participant Flow:   Overall Study
    Baby-guardTM   Baby-guardTM Minimal Inflation
STARTED   40   40 
COMPLETED   40   40 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 Baby-guardTM system, with minimal inflation in women who expected natural delivery
Total Total of all reporting groups

Baseline Measures
   Baby-guardTM   Baby-guardTM With Minimal Inflation   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   40   40   80 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.97  (5.16)   31.45  (1.2)   31.1  (2.2) 
Gender 
[Units: Participants]
     
Female   40   40   80 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   40   40   80 
Region of Enrollment 
[Units: Participants]
     
Italy   40   40   80 


  Outcome Measures

1.  Primary:   Partecipant With Perineal Laceration   [ Time Frame: after delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Erich Cosmi
Organization: University of Padua
phone: +393398146745
e-mail: ecosmi@hotmail.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Erich Cosmi MD, PhD, University of Padua
ClinicalTrials.gov Identifier: NCT01566331     History of Changes
Other Study ID Numbers: unipd
Study First Received: March 19, 2012
Results First Received: May 19, 2014
Last Updated: October 17, 2016