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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
500mg azithromycin PO for seven days starting on admission
1000mg azithromycin PO once at admission
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Azithromycin trough in amniotic fluid
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
Time frame: 8 days
IL-6 in amniotic fluid
Mean difference in IL-6 at delivery or 8 days (which ever is first)
Time frame: 8 days
IL-8 in cord blood
Mean difference in IL-8 in cord blood
Time frame: 3 months (delivery)
Respiratory ureaplasma colonization in neonate
Culture of nasopharyngeal swab within 48 hours of delivery in neonates
Time frame: 3 months
Latency to delivery
Number days from admission to delivey
Time frame: 3 months
Intra-amniotic infection
Incidence of maternal intra-amniotic infection at delivery
Time frame: 3 months (delivery)
Trend in amniotic fluid cytokines
TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission
Time frame: 8 days
ureaplasma colonization of membranes
Culture swab taken of membranes after delivery
Time frame: 3 months
Histologic chorioamnionitis
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incidence of histologic chorioamnionitis in placental pathology
Time frame: 3 months (delivery)