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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Plexus Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01739543
First received: November 29, 2012
Last updated: March 14, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Plexus Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01739543     History of Changes
Other Study ID Numbers: PB_002
Study First Received: November 29, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014