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

Not Applicable

Not yet recruiting

• Conditions: Vaginal Delivery; Surgical Site Infection
• Interventions: Drug: Chlorhexidine; Drug: Povidone-Iodine

• Registration Number: NCT05122169
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-16
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-26
• Study Start: 2021-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorhexidine	Chlorhexidine	Pre-vaginal delivery skip prep using chlorhexidine-alcohol
Povidone-iodine	Povidone-Iodine	Pre-vaginal delivery skip prep using Povidone-iodine

Primary Outcome Measures

Name	Time	Method
Number of participant with episiotomy site infection	21 days	Superficial or deep infection of episiotomy site