Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline (NCT06072352) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
3,500 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A composite of endometritis, wound infection, or other infection
Timeframe: delivery to within six weeks of delivery