search
Back to results

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

Primary Purpose

Vaginal Delivery, Surgical Site Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Povidone-Iodine
Chlorhexidine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginal Delivery focused on measuring Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    chlorhexidine

    Povidone-iodine

    Arm Description

    Pre-vaginal delivery skip prep using chlorhexidine-alcohol

    Pre-vaginal delivery skip prep using Povidone-iodine

    Outcomes

    Primary Outcome Measures

    Number of participant with episiotomy site infection
    Superficial or deep infection of episiotomy site

    Secondary Outcome Measures

    Full Information

    First Posted
    November 8, 2021
    Last Updated
    November 16, 2021
    Sponsor
    Seoul National University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05122169
    Brief Title
    Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery
    Official Title
    Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Delivery, Surgical Site Infection
    Keywords
    Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    4140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chlorhexidine
    Arm Type
    Experimental
    Arm Description
    Pre-vaginal delivery skip prep using chlorhexidine-alcohol
    Arm Title
    Povidone-iodine
    Arm Type
    Active Comparator
    Arm Description
    Pre-vaginal delivery skip prep using Povidone-iodine
    Intervention Type
    Drug
    Intervention Name(s)
    Povidone-Iodine
    Other Intervention Name(s)
    Povidone-iodine 10%
    Intervention Description
    Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine
    Other Intervention Name(s)
    Hexitanol 2% Soln., Chlorhexidine Gluconate Solution
    Intervention Description
    Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.
    Primary Outcome Measure Information:
    Title
    Number of participant with episiotomy site infection
    Description
    Superficial or deep infection of episiotomy site
    Time Frame
    21 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs