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NCT01739543 Clinical Trial

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

Complications; Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01739543
Other study ID # PB_002
Secondary ID
Status Completed
Phase N/A
First received November 29, 2012
Last updated March 14, 2013
Start date April 2012
Est. completion date January 2013

Study information
Verified date March 2013
Source Plexus Biomedical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Hem-Avert
Application of Hem-Avert

Locations
Country Name City State
United States Niagara Falls Memorial Medical Center Niagara Falls New York

Sponsors (1)
Lead Sponsor Collaborator
Plexus Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduce C-section Rate 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 No
Secondary Reduce duration of 2nd stage of labor. 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 No
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