The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial

Trials

Study Protocol

Kyung A Lee¹  Mi Hye Park¹  Min-Jeong Oh²  Geum Joon Cho²  Eun Saem Choi³  Ki Hoon Ahn³  Soon-Cheol Hong³  Ji-Hee Sung⁴  Cheong-Rae Roh⁴  Sun Min Kim⁵  Byoung Jae Kim⁵  Hyeon Ji Kim⁶  Seung Mi Lee⁷  Joong Shin Park⁷  Young Mi Jung⁷  Kyung Joon Oh⁸  In Yang Park⁹  Subeen Hong⁹  So Yeon Kim^1,10  Jin Hoon Chung^1,10  Hye-Sung Won^1,10 

[1] Department of Obstetrics and Gynecology, Ewha Womans University Seoul Hospital, College of Medicine, Ewha Womans University, Seoul, South Korea;Department of Obstetrics and Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, South Korea;Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea;Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea;Department of Obstetrics and Gynecology, Korea University Anam Hospital, Seoul, South Korea;Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea;Department of Obstetrics and Gynecology, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, Seoul, South Korea;Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea;Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, 03080, Seoul, South Korea;Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, 03080, Seoul, South Korea;Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea;Department of Obstetrics and Gynecology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea;Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea;

关键词: Antiseptic;    Perineal infection;    Vaginal delivery;    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07101-w

 received in 2022-11-02, accepted in 2023-01-18,  发布年份 2023

来源: Springer

【 摘 要 】

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.Trial registrationClinicalTrials.gov NCT05122169. First submitted date on 8 November 2021. First posted date on 16 November 2021

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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