Status:
COMPLETED
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Christiana Care Health Services
Conditions:
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
14-65 years
Phase:
PHASE4
Brief Summary
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 2...
Detailed Description
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 2...
Eligibility Criteria
Inclusion
- Singleton gestation 24 0/7 -33 0/7 weeks'
- Diagnosed with preterm premature rupture of membranes:
- History consistent with ruptured membranes (ie leaking, gush of fluid)
- Sterile speculum exam with pooling
- Fluid positive for ferning and/or nitrazine
- With or without confirmatory test such as Amnisure
Exclusion
- • Contraindication to azithromycin
- Active labor, abruption, chorioamnionitis at enrollment
- Other contraindication to expectant management of PPROM at enrollment
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04294069
Start Date
September 14 2020
End Date
April 1 2021
Last Update
July 27 2023
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107