NCT05122169

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,140

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Dec 2021

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Dec 2021May 2026

First Submitted

Initial submission to the registry

November 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

4.1 years

First QC Date

November 8, 2021

Last Update Submit

November 16, 2021

Conditions

Vaginal DeliverySurgical Site Infection

Keywords

Chlorhexidine-alcoholPovidone-iodinePerineal infectionSurgical site infection

Outcome Measures

Primary Outcomes (1)

  • Number of participant with episiotomy site infection

    Superficial or deep infection of episiotomy site

    21 days

Study Arms (2)

chlorhexidine

EXPERIMENTAL

Pre-vaginal delivery skip prep using chlorhexidine-alcohol

Drug: Chlorhexidine

Povidone-iodine

ACTIVE COMPARATOR

Pre-vaginal delivery skip prep using Povidone-iodine

Drug: Povidone-Iodine

Interventions

Povidone-IodineDRUG

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

Also known as: Povidone-iodine 10%
Povidone-iodine
ChlorhexidineDRUG

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

Also known as: Hexitanol 2% Soln., Chlorhexidine Gluconate Solution
chlorhexidine

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36810189DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-IodineChlorhexidine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 16, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

November 26, 2021

Record last verified: 2021-11