5 results
Primary:to evaluate the effects of a moderate CYP3A4/5 inhibitor, diltiazem on the pharmacokinetics and pharmacodynamics (Thrombin and TRAP-induced platelet aggregation) of the study drug and its known metabolitessecundary:to evaluate the effects of…
To assess whether testing for fibronectin is a cost-effective strategy that prevents unnecessary treatment in women with threatened preterm labour.
To assess whether in women with early PPROM tocolytics improve perinatal outcome.
To evaluate the effectiveness of tocolytic maintenance therapy for postponing delivery after initial 48-hour tocolytic therapy in women with threatened preterm birth from 24-32 weeks gestational age.
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…