Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes

NCT04516226 | Unknown

• 1 other identifier: 5743
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pregnancy latency

  The time measured in days from the diagnosis of pre labor premature rupture of membranes (PPROM) to delivery.

  Delivery

Secondary Outcomes (10)

• Serum inflammatory markers

  Within 24 hours of admission, 7 days after admission, day of delivery

• Amniotic fluid inflammatory markers

  Within 24 hours of admission, 7 days after admission, day of delivery

• White blood cell count, cells per liter

  Within 24 hours of admission, 7 days after admission, day of delivery

• Number of participants with clinical chorioamnionitis

  Through study completion, an average of 1 year

• Rate of placental abnormalities on pathology evaluation

  studied postpartum, up to 1 week

Study Arms (2)

Vaginal cleansing

EXPERIMENTAL

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

Other: Vaginal cleansing with chlorhexidine gluconate solution

No vaginal cleansing

NO INTERVENTION

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

Interventions

Vaginal cleansing with chlorhexidine gluconate solution OTHER

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

Vaginal cleansing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Central Study Contacts

Albany Research Coordinator

CONTACT

518-262-4942; Obgynresearch@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 18, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)