What side effects are associated with this type of intervention?

Chlorhexidine gluconate, used for vaginal cleansing in cases of PROM, can cause local irritation and allergic reactions. Other common treatments for PROM include antibiotics, which may lead to gastrointestinal disturbances, allergic reactions, and antibiotic resistance, and corticosteroids, which can cause hyperglycemia, increased risk of infection, and potential impacts on fetal growth. These treatments aim to reduce infection risk and improve neonatal outcomes.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments of Premature Rupture of Membranes (PROM) that are similar to chlorhexidine gluconate. Chlorhexidine gluconate is an antiseptic that disrupts microbial cell membranes and is being studied for vaginal cleansing in cases of preterm pre-labor rupture of membranes (PPROM). Generally, the management of PROM includes the use of antibiotics to prevent infection and corticosteroids to enhance fetal lung maturity, but specific antiseptic treatments like chlorhexidine gluconate are still under investigation.

What other types of research exist?

Promising novel alternatives to vaginal cleansing with chlorhexidine gluconate for PROM patients include the use of probiotics to maintain healthy vaginal flora, antimicrobial peptides that target specific pathogens without disrupting beneficial microbes, and the application of bacteriophage therapy to selectively eliminate harmful bacteria. Additionally, advancements in nanotechnology-based antimicrobial agents and the use of silver nanoparticles have shown potential in preventing infections associated with PROM.

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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

Must not have

Maternal sepsis or chorioamnionitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1 year

Awards & highlights

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an infection in my uterus during pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pregnancy latency

Secondary study objectives

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chlorhexidine gluconate is an antiseptic that works by disrupting microbial cell membranes, leading to cell death. This mechanism is crucial for patients with Premature Rupture of Membranes (PROM) as it helps to minimize the risk of infection, which can be a significant complication in these cases. By reducing the microbial load in the vaginal area, chlorhexidine gluconate can help prolong pregnancy latency and improve maternal and neonatal outcomes.

Reaction of vaginal tissue of rabbits to inserted sponges made of various materials.Anti-infective drugs in obstetrics and gynecology.[Subcutaneous implantation type central venous port management in patients with malignant tumors effect of different antiseptic agents on central venous port-related infection].