A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
Not Applicable
Completed
- Conditions
- Complications; Cesarean Section
- Interventions
- Device: Hem-Avert
- Registration Number
- NCT01739543
- Lead Sponsor
- Stetrix, Inc.
- Brief Summary
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Hem-Avert Subject receives Hem-Avert Device.
- Primary Outcome Measures
Name Time Method Reduce C-section Rate 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
- Secondary Outcome Measures
Name Time Method Reduce duration of 2nd stage of labor. 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
Trial Locations
- Locations (1)
Niagara Falls Memorial Medical Center
🇺🇸Niagara Falls, New York, United States