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NOT YET RECRUITING
NCT06072352
NA

Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3500

Start Date

2023-10-01

Completion Date

2026-12-31

Last Updated

2023-10-10

Healthy Volunteers

No

Interventions

OTHER

Perineal cleansing using chlorhexidine acetate solution

Perineal cleansing using chlorhexidine acetate solution

OTHER

Normal saline

Perineal cleansing using normal saline