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

Ferring

Status and phase

Completed

Phase 2

Conditions

Labor, Premature

Premature Birth

Treatments

Drug: FE200440

Study type

Interventional

Funder types

Industry

Identifiers

NCT00209326

FE200440 CS004

Details and patient eligibility

About

• 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

Full description

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

Enrollment

163 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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