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

Young Mi Jung, Seung Mi Lee, So Yeon Kim, Jin Hoon Chung, Hye Sung Won, Kyung A. Lee, Mi Hye Park, Geum Joon Cho, Min Jeong Oh, Eun Saem Choi, Ki Hoon Ahn, Soon Cheol Hong, Ji Hee Sung, Cheong Rae Roh, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Kim, Kyung Joon Oh, Subeen Hong, In Yang ParkJoong Shin Park

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Cleansing 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. Methods: In 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. Discussion: This 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 registration: ClinicalTrials.gov NCT05122169. First submitted date on 8 November 2021.

Original languageEnglish
Article number130
JournalTrials
Volume24
Issue number1
DOIs
StatePublished - Dec 2023

Bibliographical note

Funding Information:
This research was supported by a grant of Patient-Centered Clinical Research Coordinating Center (PACEN) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HC21C0090). The funding body had no role in the design of the protocol and will not have any role in the conduct of the study including the collection, analysis, and interpretation of data; the writing of the manuscript; or the decision to publish.

Publisher Copyright:
© 2023, The Author(s).

Keywords

  • Antiseptic
  • Perineal infection
  • Randomized controlled trial
  • Vaginal delivery

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