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

NCT02562547 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 799

Last updated 2015-09-29

No results posted yet for this study

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.

Conditions

  • Cesarean Section Rate

Interventions

DEVICE

Hem-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.

Sponsors & Collaborators

  • Desert Perinatal Associates

    lead OTHER

Principal Investigators

  • Craig Weiner, M.D. · Dignity Health

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02562547 on ClinicalTrials.gov