Skip to main content
Clinical Trials/NCT06072352
NCT06072352
Not yet recruiting
Not Applicable

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

The University of Hong Kong0 sites3,500 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Infection During Pregnancy
Sponsor
The University of Hong Kong
Enrollment
3500
Primary Endpoint
A composite of endometritis, wound infection, or other infection
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

A composite of endometritis, wound infection, or other infection

Time Frame: delivery to within six weeks of delivery

endometritis, wound infection, or other infection

Similar Trials