Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

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

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.

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.

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