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

Seoul National University

Status: Not yet enrolling

Conditions: Surgical Site Infection; Vaginal Delivery

Treatments: Drug: Povidone-Iodine; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05122169

Vaginal Delivery Skin Prep

Details and patient eligibility

About

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.

Enrollment: 4,140 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,140 participants in 2 patient groups

chlorhexidine

Experimental group

Description:

Pre-vaginal delivery skip prep using chlorhexidine-alcohol

Treatment:

Drug: Chlorhexidine

Povidone-iodine

Active Comparator group

Description:

Pre-vaginal delivery skip prep using Povidone-iodine

Treatment:

Drug: Povidone-Iodine