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Completed

NCT Number: NCT01739543

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

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

Completed

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Key information

Conditions

Complications; Cesarean Section

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Niagara Falls Memorial Medical Center

Niagara Falls, New York, 14301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hem-Avert

Device

Application of Hem-Avert

Other names: Hem-Avert Perianal Stabilizer

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stetrix, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2012
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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