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

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