drugset / Trial / NCT04202380

Azithromycin for Preterm Pre-labor Rupture of Membranes

NCT04202380

Completed 300 enrolled Assiut University
RandomizedParallel-groupOpen-labelPrevention

Summary

The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management. One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.

Timeline

Start
2020-01-01
Primary completion
2021-01-01
Completion
2021-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg Oral
Subject Azithromycin Small molecule 1000 mg Oral
Background Ampicillin Unknown 2 g Intravenous