Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02562547

Enrollment

799

Registered

2015-09-29

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2015-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Rate

Brief summary

This is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.

Detailed description

The on label device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This study is being sponsored by Dignity Health and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 801.109. Retrospective data will be collected in this study on the reduction of c-section rates and duration of second stage of labor. These data may be used to support an application to the FDA for a new indication of reducing c-sections. It is also possible the second stage labor data may also be used in support of expanded labeling.

Interventions

DEVICEHem-Avert Perianal Stabilizer

The HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Vaginal Births

Exclusion criteria

* Anticipated non-vaginal birth

Design outcomes

Primary

Measure	Time frame	Description
Cesarean Conversion Rate	90 Days	Cesarean Conversion Rate

Secondary

Measure	Time frame	Description
Second stage labor times	90 Days	Comparing second stage labor times
Lacerations	90 Days	Comparing lacerations

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026