Preterm Premature Rupture of Membrane
Conditions
Brief 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.
Detailed 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.
Interventions
500mg azithromycin PO for seven days starting on admission
1000mg azithromycin PO once at admission
Sponsors
Christiana Care Health Services
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Azithromycin trough in amniotic fluid | 8 days | Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-8 in cord blood | 3 months (delivery) | Mean difference in IL-8 in cord blood |
| Respiratory ureaplasma colonization in neonate | 3 months | Culture of nasopharyngeal swab within 48 hours of delivery in neonates |
| Latency to delivery | 3 months | Number days from admission to delivey |
| IL-6 in amniotic fluid | 8 days | Mean difference in IL-6 at delivery or 8 days (which ever is first) |
| Trend in amniotic fluid cytokines | 8 days | TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission |
| ureaplasma colonization of membranes | 3 months | Culture swab taken of membranes after delivery |
| Histologic chorioamnionitis | 3 months (delivery) | incidence of histologic chorioamnionitis in placental pathology |
| Intra-amniotic infection | 3 months (delivery) | Incidence of maternal intra-amniotic infection at delivery |
Countries
United States
Outcome results
None listed