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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739543
First Posted: December 3, 2012
Last Update Posted: March 18, 2013
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.
Information provided by (Responsible Party):
Plexus Biomedical, Inc.
  Purpose
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Condition Intervention
Complications; Cesarean Section Device: Hem-Avert

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Plexus Biomedical, Inc.:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 102
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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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).
  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): 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
  More Information

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 Submitted: November 29, 2012
First Posted: December 3, 2012
Last Update Posted: March 18, 2013
Last Verified: March 2013