The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial
- 주제(키워드) Antiseptic , Perineal infection , Vaginal delivery , Randomized controlled trial
- 주제(기타) Medicine, Research & Experimental
- 설명문(일반) [Jung, Young Mi; Lee, Seung Mi; Oh, Kyung Joon; Park, Joong Shin] Seoul Natl Univ, Dept Obstet & Gynecol, Coll Med, 101 Daehak ro, Seoul 03080, South Korea; [Kim, So Yeon; Chung, Jin Hoon; Won, Hye-Sung] Univ Ulsan, Asan Med Ctr, Dept Obstet & Gynecol, Coll Med, Seoul, South Korea; [Lee, Kyung A.; Park, Mi Hye] Ewha Womans Univ, Ewha Womans Univ Seoul Hosp, Coll Med, Dept Obstet & Gynecol, Seoul, South Korea; [Cho, Geum Joon; Oh, Min-Jeong] Korea Univ, Guro Hosp, Coll Med, Dept Obstet & Gynecol, Seoul, South Korea; [Cho, Geum Joon; Oh, Min-Jeong; Choi, Eun Saem; Ahn, Ki Hoon; Hong, Soon-Cheol] Korea Univ, Dept Obstet & Gynecol, Coll Med, Seoul, South Korea; [Choi, Eun Saem; Ahn, Ki Hoon; Hong, Soon-Cheol] Korea Univ Anam Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Sung, Ji-Hee; Roh, Cheong-Rae] Sungkyunkwan Univ, Samsung Med Ctr, Dept Obstet & Gynecol, Sch Med, Seoul, South Korea; [Kim, Sun Min; Kim, Byoung Jae] Seoul Natl Univ, Dept Obstet & Gynecol, Seoul Metropolitan Govt, Boramae Med Ctr, Seoul, South Korea; [Kim, Hyeon Ji; Oh, Kyung Joon] Seoul Natl Univ, Dept Obstet & Gynecol, Bundang Hosp, Seongnam Si, Gyeonggi Do, South Korea; [Hong, Subeen; Park, In Yang] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Obstet & Gynecol, Seoul, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 BMC
- 발행년도 2023
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000204243
- 본문언어 영어
- Published As https://doi.org/10.1186/s13063-023-07101-w
초록/요약
BackgroundCleansing of the vulva and perineum is recommended during preparation for vaginal delivery, and special attention is paid to cleansing before episiotomy because episiotomy is known to increase the risk of perineal wound infection and/or dehiscence. However, the optimal method of perineal cleansing has not been established, including the choice of antiseptic agent. To address this issue, we designed a randomized controlled trial to examine whether skin preparation with chlorhexidine-alcohol is superior to povidone-iodine for the prevention of perineal wound infection after vaginal delivery.MethodsIn this multicenter randomized controlled trial, term pregnant women who plan to deliver vaginally after episiotomy will be enrolled. The participants will be randomly assigned to use antiseptic agents for perineal cleansing (povidone-iodine or chlorhexidine-alcohol). The primary outcome is superficial or deep perineal wound infection within 30 days after vaginal delivery. The secondary outcomes are the length of hospital stay, physician office visits, or hospital readmission for infection-related complications, endometritis, skin irritations, and allergic reactions.DiscussionThis study will be the first randomized controlled trial aiming to determine the optimal antiseptic agent for the prevention of perineal wound infections after vaginal delivery.
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