Premature Birth Clinical Trial
Official title:
A Randomised, Double-blind, Parallel Group, Dose-ranging, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 (0.3, 1, 3, 10 mg) and Placebo on Stopping Preterm Labour and Uterine Contractions in Pregnant Women With Advanced Gestational Age
• To determine the effects of four different single bolus doses of FE200440 administered intravenously on stopping preterm labour compared to placebo in pregnant women with advanced gestational age
- To determine the effects of four different single bolus doses of FE200440 administered
intravenously on stopping preterm labour compared to placebo in pregnant women with
advanced gestational age
- To establish the effects of four different single bolus doses of FE200440 administered
intravenously on uterine contractions compared to placebo
- To evaluate the effects of four different single bolus doses of FE200440 administered
intravenously on labour progression compared to placebo
- To establish the dose-response curve of single bolus doses of FE200440 administered
intravenously in terms of time to delivery, uterine contractions and labour progression
- To determine the duration of action of four different single bolus doses of FE200440
administered intravenously in terms of time to delivery, uterine contractions and
labour progression
- To establish the pharmacokinetic parameters of FE200440 after single bolus intravenous
administration
- To determine the relation between plasma concentrations of FE200440 and uterine
contractions and labour progression
- To compare the maternal, fetal and infant safety profile after intravenous
administration of four different single bolus doses of FE200440 and placebo
- To evaluate the impact of four different single bolus doses of FE200440 administered
intravenously on delivery outcome, postpartum events and lactation
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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