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Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Primary Purpose

Maternal Infection During Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perineal cleansing using chlorhexidine acetate solution
Normal saline
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Infection During Pregnancy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All women age ≥ 18 years old Live singleton pregnancy Planned vaginal delivery Term in labour (after 37+0 weeks of gestation) Availability of GBS result at 35-37 weeks Exclusion Criteria: Preterm delivery (between 24+0 to 36+6 weeks of gestation) Multiple pregnancy Presence of fever before onset of labour History of antibiotics use 7 days before onset of labour History of adverse reaction to chlorhexidine Planned Caesarean delivery Planned delivery in other units Women with autoimmune disease, immunodeficiency, human immunodeficiency virus or on long term steroids Stillbirth Known genital herpes Genital wart during pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Chlorhexidine acetate solution

    Normal saline

    Arm Description

    Outcomes

    Primary Outcome Measures

    A composite of endometritis, wound infection, or other infection
    endometritis, wound infection, or other infection

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 2, 2023
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06072352
    Brief Title
    Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
    Official Title
    A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Maternal infection during pregnancy is one of the leading causes of maternal mortality, accounting for 10.7% of maternal deaths worldwide (~37,000 annually). Majority of maternal infection occurs during intrapartum (36%) and postpartum (47%) period, of which the genital tract is the source of infection in 89% of intrapartum and 54% of postpartum sepsis. Introduction of skin flora into the genital tract during vaginal examination in women with rupture of membranes or active labour may cause intrapartum and puerperal sepsis. We hypothesize intrapartum vulval and perineal cleansing before vaginal examination could reduce the chance of peripartum infection caused by introducing the skin flora to intrauterine environment. We plan to carry out a randomized controlled trial of intrapartum vulval and perineal cleansing using chlorhexidine, compared sterile water, prior to vaginal examination during labour and its effect on maternal and neonatal sepsis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Infection During Pregnancy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chlorhexidine acetate solution
    Arm Type
    Experimental
    Arm Title
    Normal saline
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Perineal cleansing using chlorhexidine acetate solution
    Intervention Description
    Perineal cleansing using chlorhexidine acetate solution
    Intervention Type
    Other
    Intervention Name(s)
    Normal saline
    Intervention Description
    Perineal cleansing using normal saline
    Primary Outcome Measure Information:
    Title
    A composite of endometritis, wound infection, or other infection
    Description
    endometritis, wound infection, or other infection
    Time Frame
    delivery to within six weeks of delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All women age ≥ 18 years old Live singleton pregnancy Planned vaginal delivery Term in labour (after 37+0 weeks of gestation) Availability of GBS result at 35-37 weeks Exclusion Criteria: Preterm delivery (between 24+0 to 36+6 weeks of gestation) Multiple pregnancy Presence of fever before onset of labour History of antibiotics use 7 days before onset of labour History of adverse reaction to chlorhexidine Planned Caesarean delivery Planned delivery in other units Women with autoimmune disease, immunodeficiency, human immunodeficiency virus or on long term steroids Stillbirth Known genital herpes Genital wart during pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

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