A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
Status:
Terminated
Trial end date:
2017-08-25
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate the superiority of retosiban to prolong
pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is
based on the hypothesis that prolonging the time to delivery in the absence of harm may
benefit the newborn, particularly in women who experience spontaneous preterm labor at early
gestational ages (GA). This study is designed to test this hypothesis through a direct
comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term
use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in
preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6
phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery,
Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females
will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of
any one subject's (maternal or neonatal) participation in the study will be variable and
dependent on GA at study entry and the date of delivery.