Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

October 2, 2023 updated by: The University of Hong Kong

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Normal saline
Perineal cleansing using normal saline
Experimental: Chlorhexidine acetate solution
Other: Perineal cleansing using 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

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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