MedDataX Logo

Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery

NCT ID: NCT05122169

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Delivery Surgical Site Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chlorhexidine-alcohol Povidone-iodine Perineal infection Surgical site infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

chlorhexidine

Pre-vaginal delivery skip prep using chlorhexidine-alcohol

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.

Povidone-iodine

Pre-vaginal delivery skip prep using Povidone-iodine

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Povidone-Iodine

Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.

Intervention Type DRUG

Chlorhexidine

Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Povidone-iodine 10% Hexitanol 2% Soln., Chlorhexidine Gluconate Solution

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women with singleton pregnancy
* Women who will undergo vaginal delivery after 37+0/7 weeks of gestation

Exclusion Criteria

* Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
* Women with any infection at perineum (before vaginal delivery)
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joong Shin Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Jung YM, Lee SM, Kim SY, Chung JH, Won HS, Lee KA, Park MH, Cho GJ, Oh MJ, Choi ES, Ahn KH, Hong SC, Sung JH, Roh CR, Kim SM, Kim BJ, Kim HJ, Oh KJ, Hong S, Park IY, Park JS. The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial. Trials. 2023 Feb 21;24(1):130. doi: 10.1186/s13063-023-07101-w.

Reference Type DERIVED
PMID: 36810189 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Vaginal Delivery Skin Prep

Identifier Type: -

Identifier Source: org_study_id