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A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer

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ClinicalTrials.gov Identifier: NCT01739543
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
Plexus Biomedical, Inc.

Brief Summary:
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Device: Hem-Avert Not Applicable

Detailed Description:
This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Investigational
Subject receives Hem-Avert Device.
Device: Hem-Avert
Application of Hem-Avert
Other Name: Hem-Avert Perianal Stabilizer
No Intervention: Control
Subject does not receive Hem-Avert Device.



Primary Outcome Measures :
  1. Reduce C-section Rate [ Time Frame: 24 hours ]
    The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates


Secondary Outcome Measures :
  1. Reduce duration of 2nd stage of labor. [ Time Frame: 24 hours ]
    A secondary objective is to evaluate the success rate of the HEM-AVERT® device as a method of reducing the duration of second stage of labor



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is scheduled for vaginal delivery.
  • Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
  • Subjects' pre-natal examination indicates that this is to be a single birth delivery.

Exclusion Criteria:

  • Subject's scheduled for vaginal delivery with anticipated complications.
  • Subject is unable to understand and sign the informed consent form.
  • Subject does not deliver at study facility (hospital).

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): NCT01739543


Locations
United States, New York
Niagara Falls Memorial Medical Center
Niagara Falls, New York, United States, 14301
Sponsors and Collaborators
Plexus Biomedical, Inc.
Investigators
Principal Investigator: Dan Burns, M.D. Unafilliated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Plexus Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01739543     History of Changes
Other Study ID Numbers: PB_002
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013