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

NCT02562547 | Completed

• 1 other identifier: DH-SR-S-01
• Study Type: observational
• Target: 799
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section Rate

Outcome Measures

Primary Outcomes (1)

• Cesarean Conversion Rate

  Cesarean Conversion Rate

  90 Days

Secondary Outcomes (2)

• Second stage labor times

  90 Days

• Lacerations

  90 Days

Study Arms (1)

All Vaginal Births

The application of the Hem-Avert Perianal Stabilizer

Device: Hem-Avert Perianal Stabilizer

Interventions

Hem-Avert Perianal Stabilizer DEVICE

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.

All Vaginal Births

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Vaginal Births

You may not qualify if:

• Anticipated non-vaginal birth

Sponsors & Collaborators

• Desert Perinatal Associates: lead

Related Publications (4)

• 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.

  PMID: 12004215 BACKGROUND

• 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.

  PMID: 8252148 BACKGROUND

• 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.

  PMID: 18468922 BACKGROUND

• 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.

  PMID: 24078876 BACKGROUND

Study Officials

• Craig Weiner, M.D.

  Dignity Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 29, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09