NCT00209326

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 16, 2011

Status Verified

December 1, 2011

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Last Update Submit

December 15, 2011

Conditions

Labor, PrematurePremature Birth

Interventions

FE200440DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

ULB Erasme Hospital Gynecology, Route de Lennik 808

Brussels, BE-1070, Belgium

Location

CHR Citadelle, Boulevard du 12iede Ligne 1

Liège, BE-4000, Belgium

Location

AZ Heilig Hart Gynecology, Kliniekstraat 44

Tienen, BE-3299, Belgium

Location

Gynekologicko-porodnicka klinika Fakultni nemocnice Brno, Obilni trh 11

Brno, CZ-625 00, Czechia

Location

Gynekologicko-porodnicke oddeleni nemocnice Jihlava, Vrchlickeho 59

Jihlava, CZ-58 501, Czechia

Location

Gynekologicka-porodnicka klinika Fakultni nemocnice, Capkovo namesti 1

Pilsen, CZ-307 08, Czechia

Location

Gynekologicko-porodnicka klinika 1. LF UK a VFN v Praze, Apolinarska 18

Prague, CZ-128 51, Czechia

Location

Gynekologicko-porodnicka klinika Fakultni nemocnice Motol, V uvalu 84

Prague, CZ-15006, Czechia

Location

Gynekologicko.porodnicke oddeleni, Socialni pece 12A

Ústí nad Labem, CZ-400 01, Czechia

Location

Kuopio University Hopital

Kuopio, FI-70210, Finland

Location

Tampere University Hospital

Tampere, FI-33521, Finland

Location

Turku University Hospital, Kiinamyllynkatu 4-6

Turku, FIN-20521, Finland

Location

Kaunas Medical University Clinics, Eiveniu 2

Kaunas, LT-50009, Lithuania

Location

Vilnius University, Antakalnio 57

Vilnius, LT-10207, Lithuania

Location

Zaklad Patofizjologii Ciazy AM w Bialymstoku, M.C. Sklodowskiej 24a

Bialystok, PO - 15-276, Poland

Location

Spitalul Clinic de Urgenta "Elias", Nr. 17, Str. Marasti, sector 1

Bucharest, RO-011461, Romania

Location

Spitalul Clinic Judetean Cluj-Napoca Ginecologie No. 1, Clinica Nr. 1 Ginecologie Nr. 3-5, Str. Clinicilor

Cluj-Napoca, RO-3400, Romania

Location

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

December 16, 2011

Record last verified: 2011-12

Locations

BE(3)CZ(6)FI(3)LI(2)PL(1)RO(2)