NCT06072352

Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,500 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maternal Infection During Pregnancy

Interventions

Type	Name	Description
OTHER	Perineal cleansing using chlorhexidine acetate solution	Perineal cleansing using chlorhexidine acetate solution
OTHER	Normal saline	Perineal cleansing using normal saline

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-10
• Last updated: 2023-10-10