Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

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 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• • Contraindication to azithromycin

• Active labor, abruption, chorioamnionitis at enrollment

• Other contraindication to expectant management of PPROM at enrollment