Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-12-31

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.

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Detailed Description

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Conditions

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Maternal Infection During Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chlorhexidine acetate solution

Group Type EXPERIMENTAL

Perineal cleansing using chlorhexidine acetate solution

Intervention Type OTHER

Perineal cleansing using chlorhexidine acetate solution

Normal saline

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type OTHER

Perineal cleansing using normal saline

Interventions

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Perineal cleansing using chlorhexidine acetate solution

Intervention Type OTHER

Normal saline

Perineal cleansing using normal saline

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No