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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014