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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05122169
Collaborator
(none)
4,140
Enrollment
2
Arms
53.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: chlorhexidine

Pre-vaginal delivery skip prep using chlorhexidine-alcohol

Drug: Chlorhexidine
Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.
Other Names:
  • Hexitanol 2% Soln., Chlorhexidine Gluconate Solution

    		•
    Active Comparator: Povidone-iodine

    Pre-vaginal delivery skip prep using Povidone-iodine

    Drug: Povidone-Iodine
    Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.
    Other Names:
  • Povidone-iodine 10%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participant with episiotomy site infection [21 days]

      Superficial or deep infection of episiotomy site

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joong Shin Park, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05122169
    Other Study ID Numbers:
    • Vaginal Delivery Skin Prep
    First Posted:
    Nov 16, 2021
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Joong Shin Park, Professor, Seoul National University Hospital
    Chlorhexidine-alcohol
    Povidone-iodine
    Perineal infection
    Surgical site infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Iodine
    Chlorhexidine
    Chlorhexidine gluconate
    Povidone-Iodine
    Povidone

    Study Results

    No Results Posted as of Nov 26, 2021