Status:
COMPLETED
A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Labor, Premature
Premature Birth
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
• 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
* 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 * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00209326
Start Date
November 1 2003
End Date
August 1 2006
Last Update
December 16 2011
Active Locations (17)
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1
ULB Erasme Hospital Gynecology, Route de Lennik 808
Brussels, Belgium, BE-1070
2
CHR Citadelle, Boulevard du 12iede Ligne 1
Liège, Belgium, BE-4000
3
AZ Heilig Hart Gynecology, Kliniekstraat 44
Tienen, Belgium, BE-3299
4
Gynekologicko-porodnicka klinika Fakultni nemocnice Brno, Obilni trh 11
Brno, Czechia, CZ-625 00