Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

NCT06072352 | Not Yet Recruiting

• 1 other identifier: UW 21-636
• Study Type: interventional
• Target: 3,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maternal Infection During Pregnancy

Outcome Measures

Primary Outcomes (1)

• A composite of endometritis, wound infection, or other infection

  endometritis, wound infection, or other infection

  delivery to within six weeks of delivery

Study Arms (2)

Chlorhexidine acetate solution

EXPERIMENTAL

Other: Perineal cleansing using chlorhexidine acetate solution

Normal saline

ACTIVE COMPARATOR

Other: Normal saline

Interventions

Perineal cleansing using chlorhexidine acetate solution OTHER

Perineal cleansing using chlorhexidine acetate solution

Chlorhexidine acetate solution

Normal saline OTHER

Perineal cleansing using normal saline

Normal saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share