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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Rate
• Intervention / Treatment: Device: Hem-Avert Perianal Stabilizer

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.

• Study Type: Observational
• Enrollment (Actual): 799

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Participants will be all women who present for vaginal delivery at Dignity Health - St. Rose, Siena Campus during the 3 month study period. The main focus of this study is to see whether the Hem-Avert® reduces Cesarean delivery among women undergoing labor and delivery. To be included in this study, by definition, the participant must be a pregnant woman.

Description

Inclusion Criteria:

• Vaginal Births

Exclusion Criteria:

• Anticipated non-vaginal birth

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Vaginal Births; The application of the Hem-Avert Perianal Stabilizer	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean Conversion Rate	Cesarean Conversion Rate	90 Days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Desert Perinatal Associates
• Investigators: Study Chair: Craig Weiner, M.D., Dignity Health

Publications and helpful links

General Publications

• 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.
• Abramowitz L, Sobhani I, Benifla JL, Vuagnat A, Darai E, Mignon M, Madelenat P. Anal fissure and thrombosed external hemorrhoids before and after delivery. Dis Colon Rectum. 2002 May;45(5):650-5. doi: 10.1007/s10350-004-6262-5.
• 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. doi: 10.1001/archfami.2.3.277.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 27, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 27, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: DH-SR-S-01