A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
Status:
Terminated
Trial end date:
2017-07-24
Target enrollment:
Participant gender:
Summary
The study's primary objective is to demonstrate the superiority of retosiban to prolong
pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized,
double-blind, parallel-group, multicenter study and will be conducted in approximately 900
females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes
in preterm labor between 24^0/7 and 33^6/7 weeks of gestation. Eligible maternal subjects
will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo
IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment
should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly
24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12
hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent
treatment was at least 7 days prior to study enrolment. Investigators have discretion to use
a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis
for perinatal group B streptococcal infection. Prior to randomization, each subject will be
stratified by progesterone treatment and gestational age. The progesterone strata will
consist of subjects on established progesterone therapy or subjects not on established
progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient
Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment,
and Neonatal Medical Review. The duration of any subject's (maternal or neonatal)
participation in the study will be variable and dependent on gestational ages (GA) at study
entry and the date of delivery.