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

Stetrix

Status: Completed

Conditions: Complications; Cesarean Section

Treatments: Device: Hem-Avert

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739543

PB_002

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Investigational

Experimental group

Description:

Subject receives Hem-Avert Device.

Treatment:

Device: Hem-Avert

Control

No Intervention group

Description:

Subject does not receive Hem-Avert Device.