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

Stetrix, Inc.102 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

102

Conditions

Complications; Cesarean Section

Interventions

Hem-AvertDEVICE

Application of Hem-Avert

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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