Status:
UNKNOWN
Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes
Lead Sponsor:
Albany Medical College
Conditions:
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 pregn...
Detailed Description
A randomized controlled trial, including pregnant women \> 18 years old with early onset PPROM occurring between the time of peri-viability through the early third trimester (20 weeks 0 days - 33 week...
Eligibility Criteria
Inclusion
- Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04516226
Start Date
August 1 2020
End Date
December 31 2024
Last Update
April 18 2023
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208