40 Participants Needed

Vaginal Cleansing With Chlorhexidine for Premature Rupture of Membranes

SC
AR
Overseen ByAlbany Research Coordinator
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Albany Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies whether cleaning the vaginal area with an antiseptic solution can help pregnant women with early water breakage stay pregnant longer. It targets women in the later stages of pregnancy to reduce infection risks and delay labor.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken antibiotics or steroids within 7 days before joining the trial.

Is vaginal cleansing with chlorhexidine safe for humans?

Research shows that vaginal cleansing with chlorhexidine is generally safe, with no adverse reactions reported in studies involving pregnant women and newborns. It has been used to reduce infections without causing harm, making it a safe option for preventing infections in various settings.12345

How is vaginal cleansing with chlorhexidine different from other treatments for premature rupture of membranes?

Vaginal cleansing with chlorhexidine is unique because it uses an antiseptic solution to reduce the risk of infections after the membranes have ruptured, which is different from other treatments that may not focus on infection prevention. Chlorhexidine is known for its strong antimicrobial properties, making it potentially more effective than other antiseptics like povidone-iodine.12678

Are You a Good Fit for This Trial?

This trial is for pregnant women diagnosed with PPROM between 20-33 weeks of gestation, without active labor or conditions like sepsis, chorioamnionitis, preeclampsia, IUGR. It excludes those who've received antibiotics or steroids within the past week, have multiple pregnancies, placenta previa, or visible fetal parts/cervical dilation at initial exam.

Inclusion Criteria

I am pregnant, diagnosed with PPROM between 20-33 weeks.

Exclusion Criteria

Placenta previa
Preeclampsia
Intrauterine growth restriction (IUGR)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis

1 day
1 visit (in-person)

Expectant Management

Participants are managed expectantly until delivery, with standard care for PPROM

Up to delivery

Follow-up

Participants are monitored for maternal and neonatal outcomes after delivery

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Vaginal cleansing with chlorhexidine gluconate solution
Trial Overview The study tests if vaginal cleansing with chlorhexidine gluconate can prolong pregnancy in women with PPROM. It's a randomized controlled trial that also looks at maternal and neonatal health outcomes and measures inflammation markers from various biological samples.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Vaginal cleansingExperimental Treatment1 Intervention
Group II: No vaginal cleansingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+

Citations

Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. [2022]
Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine. [2016]
Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. [2023]
Efficacy and safety of whole body skin cleansing with chlorhexidine in neonates--a systemic review. [2023]
An intervention to reduce the risk of mother-to-infant HIV transmission: results of a pilot toxicity study. [2013]
Is preoperative vaginal cleansing necessary for control of infection after first trimester vacuum curettage? [2013]
A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation. [2021]
Chlorhexidine gel versus aqueous for preventive use on umbilical stump: a randomized noninferiority trial. [2013]
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