Status:
NOT_YET_RECRUITING
Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
Lead Sponsor:
The University of Hong Kong
Conditions:
Maternal Infection During Pregnancy
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT06072352
Start Date
October 1 2023
End Date
December 31 2026
Last Update
October 10 2023
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