Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perineal cleansing using chlorhexidine acetate solution, Normal saline.
- Who it may be relevant to
- Registry conditions: Maternal Infection During Pregnancy. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Perineal cleansing using chlorhexidine acetate solution
Perineal cleansing using chlorhexidine acetate solution - Other Normal saline
Perineal cleansing using normal saline
Primary outcome measures
- A composite of endometritis, wound infection, or other infection [Time frame: delivery to within six weeks of delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06072352 · UW 21-636