Status:
UNKNOWN
Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes
Lead Sponsor:
Eastern Virginia Medical School
Conditions:
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Aim 1. To examine the latency period according to antibiotic regimens (erythromycin iv for two days followed by orally for 5 days vs. azithromycin iv for 2 days followed by 5 days orally). Aim 2. To ...
Detailed Description
Significant differences exist in the pharmacokinetics and pharmacodynamics pathways of macrolide antibiotics between different races and ethnicities. Erythromycin compared to azithromycin interacts wi...
Eligibility Criteria
Inclusion
- Singleton pregnancy
- PPROM from 22 weeks 0 days to 31 weeks 6 days at Sentara Norfolk General Hospital
- Membrane rupture within 36 hours of randomization, cervical dilation 3 cm or less, and 4 or fewer contractions in the 60-minutes monitoring before randomization
Exclusion
- Non-reassuring fetal heart tracing
- Vaginal bleeding
- Indications for delivery
- Received any antibiotic therapy within 7 days other than initiation of Ampicillin treatment as part of latency antibiotics prior to transfer to Sentara Norfolk General Hospital
- Allergy to penicillin, erythromycin, or azithromycin
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05328817
Start Date
May 1 2022
End Date
July 1 2025
Last Update
April 14 2022
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