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Vaginal Cleansing With Chlorhexidine for Premature Rupture of Membranes

N/A
Recruiting
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights

Study Summary

This trial will study the effect of vaginal cleansing with a chemical on pregnancy in women with premature ruptured membranes. Outcomes will focus on mother, baby and inflammation markers.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include local irritation or allergic reactions to chlorhexidine gluconate. Since it's used externally for cleansing purposes, systemic side effects are less common but could involve skin sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pregnancy latency
Secondary outcome measures
Amniotic fluid inflammatory markers
Number of participants with clinical chorioamnionitis
Rate of histologic chorioamnionitis
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vaginal cleansingExperimental Treatment1 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 cleansingActive Control1 Intervention
This group includes patients diagnosed with PPROM that are randomized to not undergo vaginal cleansing.

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
91 Previous Clinical Trials
11,457 Total Patients Enrolled

Media Library

Vaginal cleansing with chlorhexidine gluconate solution Clinical Trial Eligibility Overview. Trial Name: NCT04516226 — N/A
Premature Rupture of Membranes Research Study Groups: Vaginal cleansing, No vaginal cleansing
Premature Rupture of Membranes Clinical Trial 2023: Vaginal cleansing with chlorhexidine gluconate solution Highlights & Side Effects. Trial Name: NCT04516226 — N/A
Vaginal cleansing with chlorhexidine gluconate solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516226 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes
2020. "Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04516226.
~6 spots leftby Dec 2024
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