Evidence map›Paper›PMID 36810189›Full record

ArticleTrials2023

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 and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05122169 (Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05122169 naunknown statusnot on this map

Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns

TypeinterventionalSponsorSeoul National University HospitalRan2021 to 2026Enrolled4,140ConditionsVaginal Delivery, Surgical Site InfectionArmsPovidone-Iodine, Chlorhexidine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 2 countries.

Young Mi Jung *Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Seung Mi Lee *Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
So Yeon KimDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Jin Hoon ChungDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Hye-Sung WonDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Kyung A LeeDepartment of Obstetrics and Gynecology, Ewha Womans University Seoul Hospital, College of Medicine, Ewha Womans University, Seoul, South Korea.
Mi Hye ParkDepartment of Obstetrics and Gynecology, Ewha Womans University Seoul Hospital, College of Medicine, Ewha Womans University, Seoul, South Korea.
Geum Joon ChoDepartment of Obstetrics and Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, South Korea.
Min-Jeong OhDepartment of Obstetrics and Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, South Korea.
Eun Saem ChoiDepartment of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea.
Ki Hoon AhnDepartment of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea.
Soon-Cheol HongDepartment of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea.
Ji-Hee SungDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Cheong-Rae RohDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Sun Min KimDepartment of Obstetrics and Gynecology, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, Seoul, South Korea.
Byoung Jae KimDepartment of Obstetrics and Gynecology, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, Seoul, South Korea.
Hyeon Ji KimDepartment of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.
Kyung Joon OhDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Subeen HongDepartment of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
In Yang ParkDepartment of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Joong Shin ParkDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. jsparkmd@snu.ac.kr.ORCID http://orcid.org/0000-0002-5246-0477
Korea University · KRSeoul National University · KRUlsan College · KREwha Womans University · KRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KR

Funding

Ministry of Health and Welfare HC21C0090
6 · The paper itself

Abstract

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

Indexed as

Anti-Infective Agents, LocalDermatologic AgentsCesarean SectionChlorhexidineEthanolFemaleHumansMulticenter Studies as TopicPovidone-IodinePregnancyRandomized Controlled Trials as TopicSurgical Wound InfectionAnti-Infective Agents, LocalChlorhexidineDermatologic AgentsEthanolPovidone-IodineAntisepticPerineal infectionRandomized controlled trialVaginal delivery

Identifiers

PMID36810189
PMCPMC9942633
OpenAlexW4321446878

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.