Recruiting

Chlorhexidine Gluconate

Sponsor:

Albany Medical College

Code:

NCT04516226

Conditions

Preterm Premature Rupture of Membrane

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Vaginal cleansing with chlorhexidine gluconate solution

Study Details

Brief summary:

Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of membranes). The primary outcome will be pregnancy latency. Secondary outcomes will include various maternal and neonatal outcomes, and inflammatory markers from maternal blood, amniotic fluid, fetal cord blood and placental analysis.

Conditions

Preterm Premature Rupture of Membrane

Study ID

NCT04516226

Start date

Aug 1, 2020

Status verified date

Apr, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks

Exclusion Criteria:

  • active preterm labor or imminent delivery expected at the time of PPROM diagnosis
  • maternal sepsis or chorioamnionitis
  • any contraindications to expectant management (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress cord prolapse)
  • preeclampsia
  • intrauterine growth restriction (IUGR)
  • no antibiotics or steroids given within 7 days prior to the time of enrollment
  • multiple gestation
  • placenta previa
  • fetal part visualized at initial exam
  • visual cervical dilation at initial exam

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vaginal cleansing

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

no intervention: No vaginal cleansing

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

Interventions

Vaginal cleansing with chlorhexidine gluconate solution

Cleansing of the vaginal walls with chlorhexidine gluconate solution for women diagnosed with PPROM

Primary outcome measure

  • Pregnancy latency [ Time Frame: Delivery ]

Central Contacts and Locations

Central contacts

Albany Research Coordinator

518-262-4942Obgynresearch@amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Albany research coordinator

518-262-4942

More Information

Sponsor

Albany Medical College

Last update posted

Apr 18, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2023-04-18.