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Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial — ADAPT  

Preterm Premature Rupture of Membrane Clinical Trial

Official title:
Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes

Clinical Trial 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.

Clinical Trial 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 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. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04294069
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase Phase 4
Start date September 14, 2020
Completion date April 1, 2021
View Details
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