Clinical trial NCT02562547: Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice
Official title: Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Rate
Lead sponsor: Desert Perinatal Associates
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 799
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Vaginal Births

Exclusion Criteria:

* Anticipated non-vaginal birth

Primary outcomes:
measure: Cesarean Conversion Rate
timeFrame: 90 Days
Secondary outcomes:
measure: Second stage labor times
timeFrame: 90 Days
measure: Lacerations
timeFrame: 90 Days
Other outcomes:
Locations:
Study officials:
affiliation: Dignity Health
name: Craig Weiner, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.