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This is a retrospective data-only study following the phased introduction of the HEM-AVERTĀ® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERTĀ® 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-AVERTĀ® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.
The on label device in this study is the HEM-AVERTĀ® 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-AVERTĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Vaginal Births | The application of the Hem-Avert Perianal Stabilizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hem-Avert Perianal Stabilizer | Device | The HEM-AVERTĀ® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERTĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Conversion Rate | Cesarean Conversion Rate | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Second stage labor times | Comparing second stage labor times | 90 Days |
| Lacerations | Comparing lacerations | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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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-AvertĀ® reduces Cesarean delivery among women undergoing labor and delivery. To be included in this study, by definition, the participant must be a pregnant woman.
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| Name | Affiliation | Role |
|---|---|---|
| Craig Weiner, M.D. | Dignity Health | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12004215 | Background | 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. | |
| 8252148 | 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. |
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| 18468922 | 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. |
| 24078876 | 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. |