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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss

NCT02762773

Acute Blood Loss Anemia Postoperative Pain Pregnancy

TERMINATED NA

Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices

NCT00711451

Pregnancy Cesarean Delivery

TERMINATED NA

The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

NCT02129894

Cesarean Section Post Operative Management

UNKNOWN PHASE3

Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

NCT00736580

Cesarean Delivery Glove Perforation

COMPLETED NA

Impact of Epidural on Trauma of the Genital Tract During Peripartum

NCT07255014

Peripartum Genital Tract Trauma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complications; Cesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Investigational

Subject receives Hem-Avert Device.

Group Type EXPERIMENTAL

Hem-Avert

Intervention Type DEVICE

Application of Hem-Avert

Control

Subject does not receive Hem-Avert Device.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hem-Avert

Application of Hem-Avert

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hem-Avert Perianal Stabilizer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes