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NCT05122169 Clinical Trial

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

Surgical Site Infection Clinical Trial

Official title:
Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05122169
Other study ID # Vaginal Delivery Skin Prep
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2021
Est. completion date May 31, 2026

Study information
Verified date November 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4140
Est. completion date May 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Povidone-Iodine
Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.
• Chlorhexidine
Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participant with episiotomy site infection Superficial or deep infection of episiotomy site 21 days
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