Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Not Applicable

Not yet recruiting

• Conditions: Maternal Infection During Pregnancy
• Interventions: Other: Normal saline; Other: Perineal cleansing using chlorhexidine acetate solution

• Registration Number: NCT06072352
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	-
Chlorhexidine acetate solution	Perineal cleansing using chlorhexidine acetate solution	-

Primary Outcome Measures

Name	Time	Method
A composite of endometritis, wound infection, or other infection	delivery to within six weeks of delivery	endometritis, wound infection, or other infection