Vaginal Cleansing With Chlorhexidine for Premature Rupture of Membranes

Overseen By Albany Research Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Albany Medical College

Must not be taking: Antibiotics, Steroids

Disqualifiers: Preterm labor, Sepsis, Preeclampsia, IUGR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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.

Eligibility Criteria

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)

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Vaginal cleansing Experimental Treatment 1 Intervention

This group includes patients diagnosed with PPROM that are randomized to undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis.

Group II: No vaginal cleansing Active Control 1 Intervention

This group includes patients diagnosed with PPROM that are randomized to not undergo vaginal cleansing.

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of whole body skin cleansing with chlorhexidine in neonates--a systemic review. [2023]

5. Kenya pubmed.ncbi.nlm.nih.gov

An intervention to reduce the risk of mother-to-infant HIV transmission: results of a pilot toxicity study. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Is preoperative vaginal cleansing necessary for control of infection after first trimester vacuum curettage? [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Chlorhexidine gel versus aqueous for preventive use on umbilical stump: a randomized noninferiority trial. [2013]