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

March 14, 2013 updated by: Stetrix, Inc.
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Niagara Falls, New York, United States, 14301
        • Niagara Falls Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
Subject receives Hem-Avert Device.
Device: Hem-Avert
Application of Hem-Avert
Other Names:
  • Hem-Avert Perianal Stabilizer
No Intervention: Control
Subject does not receive Hem-Avert Device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stetrix, Inc.

Investigators

  • Principal Investigator: Dan Burns, M.D., Unafilliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • PB_002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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