Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Normal saline
|
Perineal cleansing using normal saline
|
|
Experimental: Chlorhexidine acetate solution
|
Perineal cleansing using chlorhexidine acetate solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A composite of endometritis, wound infection, or other infection
Time Frame: delivery to within six weeks of delivery
|
endometritis, wound infection, or other infection
|
delivery to within six weeks of delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 21-636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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