Vaginal Cleansing With Chlorhexidine for Premature Rupture of Membranes

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Albany Medical College

No Placebo Group

Trial Summary

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)

Treatment Details

Interventions

• Vaginal cleansing with chlorhexidine gluconate solution (Behavioural Intervention)

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+