A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor

Study Overview
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Brief Summary
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• 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

Detailed Description
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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

Official Title
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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

Conditions
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Labor, Premature, Premature Birth

Intervention / Treatment
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* Drug: FE200440


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form, prior to screening evaluations Mother and fetus in good general health Pregnant women age ≥ 18 years Gestational age (verified by early ultrasound or if an ultrasound is not available by Last Menstrual Period) between 34 weeks + 0 days and 35 weeks + 6 days (both days inclusive) At randomisation, there must be 6 or more uterine contractions of at least 30 seconds duration during a 30 minutes interval At randomisation, the cervical length must be ≤ 15 mm (by transvaginal ultrasound) At randomisation, the cervical dilatation must be >1 cm and <4 cm (by vaginal examination Exclusion Criteria: Contraindications for the mother or the fetus to stop labour, including clinical suspicion of abruptio placenta known or suspected infection (e.g. urinary tract infection, chorioamnionitis) Controlled or uncontrolled diabetes mellitus (pre-gestational or gestational) Eclampsia or severe preeclampsia in the current pregnancy Previous major uterine surgery (e.g. myomectomy for leiomyomas), congenital uterine abnormalities, large leiomyomas, or retained intrauterine device Rupture of membrane in the current pregnancy Placenta praevia in the current pregnancy a) Oligohydramnios or polyhydramnios in the current pregnancy defined as amniotic fluid index (AFI) below 7.2 cm or above 27.8 cm Fetal weight (based on ultrasound) outside the ± 2SD limits provided in Appendix B Use of cervical cerclage in the current pregnancy Current multiple pregnancy Fetal death in utero in previous or current pregnancy Fetus with known or suspected abnormal karyotype or major malformations in the current pregnancy Abnormal fetal heart rate which the Investigator judges to reflect fetal distress Treatment with nifedipine, non-steroidal anti-inflammatory agents (NSAIDs) or intravenously administered magnesium sulphate for contractions during the current pregnancy or treatment with beta-mimetics, atosiban or progesterone within the last 7 days prior to randomisation Treatment with anticoagulation or fibrinolytic therapies prior to screening, or known or suspected or past history of thromboembolic disorders Known, suspected or past history of hypocoagulability or coagulation deficiency conditions Known or suspected hemoglobinopathies Use of any investigational drug during the current pregnancy Known, suspected or past history (last 12 months) of alcohol or drug abuse Known hypersensitivity to the active ingredient or to any of its excipients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FE200440|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |