Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection

Conditions
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Maternal Infection During Pregnancy

Intervention / Treatment
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* Other: Perineal cleansing using chlorhexidine acetate solution
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine acetate solution<br> | Other: Perineal cleansing using chlorhexidine acetate solution<br>* Perineal cleansing using chlorhexidine acetate solution<br>|
| Active Comparator: Normal saline<br> | Other: Normal saline<br>* Perineal cleansing using normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of endometritis, wound infection, or other infection | endometritis, wound infection, or other infection | delivery to within six weeks of delivery |