Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Maternal Infection During Pregnancy

Treatments: Other: Normal saline; Other: Perineal cleansing using chlorhexidine acetate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06072352

UW 21-636

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,500 participants in 2 patient groups

Chlorhexidine acetate solution

Experimental group

Treatment:

Other: Perineal cleansing using chlorhexidine acetate solution

Normal saline

Active Comparator group

Treatment:

Other: Normal saline