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

N/ANot Yet RecruitingNCT05122169

Seoul National University Hospital4,140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

4,140

Conditions

Vaginal Delivery Surgical Site Infection

Interventions

Povidone-IodineDRUG

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

ChlorhexidineDRUG

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

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of participant with episiotomy site infection

Superficial or deep infection of episiotomy site

Time frame: 21 days

Data from ClinicalTrials.gov

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