Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06072352

Collaborator

(none)

3,500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Infection During Pregnancy	Other: Perineal cleansing using chlorhexidine acetate solution Other: Normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chlorhexidine acetate solution	Other: Perineal cleansing using chlorhexidine acetate solution Perineal cleansing using chlorhexidine acetate solution
Active Comparator: Normal saline	Other: Normal saline Perineal cleansing using normal saline

Arm

Intervention/Treatment

Experimental: Chlorhexidine acetate solution

Other: Perineal cleansing using chlorhexidine acetate solution

Perineal cleansing using chlorhexidine acetate solution

Active Comparator: Normal saline

Other: Normal saline

Perineal cleansing using normal saline

Outcome Measures

Primary Outcome Measures

A composite of endometritis, wound infection, or other infection [delivery to within six weeks of delivery]
endometritis, wound infection, or other infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT06072352

Other Study ID Numbers:

UW 21-636

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Chlorhexidine

Chlorhexidine gluconate

Study Results

No Results Posted as of Oct 10, 2023