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

Overview

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.

Full Title of Study: “Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2015

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

  • 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.

Arms, Groups and Cohorts

  • All Vaginal Births
    • The application of the Hem-Avert Perianal Stabilizer

Clinical Trial Outcome Measures

Primary Measures

  • Cesarean Conversion Rate
    • Time Frame: 90 Days
    • Cesarean Conversion Rate

Secondary Measures

  • Second stage labor times
    • Time Frame: 90 Days
    • Comparing second stage labor times
  • Lacerations
    • Time Frame: 90 Days
    • Comparing lacerations

Participating in This Clinical Trial

Inclusion Criteria

  • Vaginal Births

Exclusion Criteria

  • Anticipated non-vaginal birth

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Desert Perinatal Associates
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Craig Weiner, M.D., Study Chair, Dignity Health

References

Abramowitz L, Sobhani I, Benifla JL, Vuagnat A, Daraï E, Mignon M, Madelenat P. Anal fissure and thrombosed external hemorrhoids before and after delivery. Dis Colon Rectum. 2002 May;45(5):650-5.

Gjerdingen DK, Froberg DG, Chaloner KM, McGovern PM. Changes in women's physical health during the first postpartum year. Arch Fam Med. 1993 Mar;2(3):277-83.

Cheng CY, Li Q. Integrative review of research on general health status and prevalence of common physical health conditions of women after childbirth. Womens Health Issues. 2008 Jul-Aug;18(4):267-80. doi: 10.1016/j.whi.2008.02.004. Epub 2008 May 12. Review.

Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013.

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