Maternal Infection During PregnancyNCT06072352
Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
A study testing Perineal cleansing using chlorhexidine acetate solution and Normal saline in people with Maternal Infection During Pregnancy, run by The University of Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Maternal Infection During Pregnancy
- What is being tested?
- Perineal cleansing using chlorhexidine acetate solution and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
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
- Being tested
- Perineal cleansing using chlorhexidine acetate solution, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal cleansing using chlorhexidine acetate solutionOther
Perineal cleansing using chlorhexidine acetate solution
Normal salineOther
Perineal cleansing using normal saline
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine acetate solution | Experimental | Not described Receives: Other: Perineal cleansing using chlorhexidine acetate solution |
| Normal saline | Active comparator | Not described Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of endometritis, wound infection, or other infection
endometritis, wound infection, or other infection
Measured: delivery to within six weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Infection During PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072352
- Sponsor's protocol ID
- UW 21-636
- Status last verified
- Sep 2023
- First submitted
- 2 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06072352
- Acronym / sponsor ID
- UW 21-636
- Conditions
- Maternal Infection During Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine acetate solution | Experimental | Other: Perineal cleansing using chlorhexidine acetate solution |
| Normal saline | Active comparator | Other: Normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal cleansing using chlorhexidine acetate solutionPerineal cleansing using chlorhexidine acetate solution | Other | Chlorhexidine acetate solution |
| Normal salinePerineal cleansing using normal saline | Other | Normal saline |
Primary outcome
A composite of endometritis, wound infection, or other infection
Time frame: delivery to within six weeks of delivery
endometritis, wound infection, or other infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal cleansing using chlorhexidine acetate solution and Normal saline in people with Maternal Infection During Pregnancy, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of endometritis, wound infection, or other infection (time frame: delivery to within six weeks of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.