Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor - Full Text View

Sponsors and Collaborators:	University Hospital, Geneva Centre Hospitalier Universitaire Vaudois University Hospital Inselspital, Berne Basel Women’s University Hospital University of Zurich Kantonsspital Chur Cantonal Hospital of St. Gallen Kantonsspital Luzern Kantonsspital Winterthur Besins Laboratory, Belgium
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00536003

Purpose

The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Condition	Intervention	Phase
Preterm Delivery Morbidity Perinatal Mortality	Drug: progesterone Drug: placebo	Phase III

Drug Information available for: Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects [ Time Frame: end of pregnancy and 28 days after delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	626
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: progesterone vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
2: Placebo Comparator	Drug: placebo vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Detailed Description:

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
Singleton pregnancy
Intact membranes
Preterm labor defined as:
- 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
- short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
- cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
- cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
- positive fetal fibronectin26-28
Age ≥ 18 years old
Signed informed consent
Possible and accepted follow-up

Exclusion Criteria:

Multiple gestation
Cervical cerclage
Hydramnios (AFI >95th percentile for gestational age or greatest pocket >8 cm)
Premature rupture of membranes
Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
Cervical dilatation > 3 cm
Placenta praevia or abruptio placentae
Intra-uterine growth restriction or non-reassuring fetal status
Pre-eclampsia or severe hypertension
Any other maternal or fetal pathology which should indicate medically preterm delivery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536003

Contacts

Contact: Begona Martinez de Tejada, MD, PhD	+ 41 22 3826816	begona.mdt@bluewin.ch
Contact: Michel Boulvain, MD, PhD	+ 41 22 3824317	michel.boulvain@hcuge.ge

Locations

Switzerland
Universitäts-Frauenklinik Kantonespital Basel	Recruiting
Basel, Switzerland, 4031
Contact: Hosli Irene, MD +41 61 265 90 17 IHoesli@uhbs.ch
Contact: Raggî Anna, MD + 41 61 265 25 25 ARaggi@uhbs.ch
Principal Investigator: Hosli Irene, MD
Sub-Investigator: Anna Raggi, MD
Universitätsfrauenklinik Bern	Recruiting
Bern, Switzerland, 3010
Contact: Daniel Surbek, MD +41 31 632 11 03 Daniel.Surbek@insel.ch
Contact: Katrin Scheibner, MD + 41 31 6321010 Katrin.Scheibner@insel.ch
Principal Investigator: Katrin Scheibner, MD
Sub-Investigator: Amann Esther, MD
Kantonales Frauenspital Chur	Recruiting
Chur, Switzerland, 7000
Contact: Kurt Biedermann, MD +41 (0)81 254 81 60 Kurt.Biedermann@ksgr.ch
Principal Investigator: Kurt Biedermann, MD
Maternity of the University Hospital of Geneva	Recruiting
Geneva, Switzerland, 1211
Contact: Begona Martinez de Tejada, MD, PhD + 41 22 3826816 begona.mdt@bluewin.ch
Contact: Michel Boulvain, MD, PhD + 41 22 3824317 michel.boulvain@hcuge.ch
Principal Investigator: Begona Martinez de Tejada, MD, PhD
Sub-Investigator: Michel Boulvain, MD
University Hospital Zürich	Recruiting
Zurich, Switzerland, 8091
Contact: Franziska Krähenmann, MD + 41 44 2555217 ext 163453 Franziska.Kraehenmann@usz.ch
Contact: Zimmermann Roland, MD + 41 44 255 5101 roland.zimmermann@usz.ch
Principal Investigator: Franziska Krähenmann, MD
Frauenklinik Kantonspital Luzern	Recruiting
Luzern, Switzerland
Contact: Markus Hodel, MD + 41 41 205 36 09 Markus Hodel@KSL.ch
Contact: Alexandra Schuler, MD + 41 41 205 36 09 alexandra.schuler@ksl.ch
Sub-Investigator: Alexandra Schuler, MD
Principal Investigator: Markus Hodel, MD
Frauenklinik Kantonspital St Gallen	Recruiting
St Gallen, Switzerland, 9007
Contact: Gero Drack, MD + 41 71 494 18 75 Gero.Drack@kssg.ch
Principal Investigator: gero Drack, MD
Frauenklinik Kantonspital Winterthur	Recruiting
Winterthur, Switzerland, 8401
Contact: Elke Prentl, MD + 41 52 266 27 62 elke.prentl@ksw.ch
Principal Investigator: Elke Prentl, MD
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Switzerland, 1011
Contact: Stephan Gerber, MD + 41 21 314 3513 stefan.gerber@chuv.hspvd.ch
Contact: Patrick Hohlfeld, MD + 41 21 314 3513 patrick.hohlfeld@chuv.hospvd.ch
Sub-Investigator: Sylvie Rouiller, MD
Principal Investigator: Stephan Gerber, MD

Sponsors and Collaborators

University Hospital, Geneva

Centre Hospitalier Universitaire Vaudois

University Hospital Inselspital, Berne

Basel Women’s University Hospital

University of Zurich

Kantonsspital Chur

Cantonal Hospital of St. Gallen

Kantonsspital Luzern

Kantonsspital Winterthur

Besins Laboratory, Belgium

Investigators

Principal Investigator:

Begona Martinez de Tejada, MD, PhD

University Hospital of Geneva

More Information

Responsible Party:	Univerity Hospital of Geneva ( Begona Martinez de Tejada )
Study ID Numbers:	CER: 04-196, matped 04-001
Study First Received:	September 24, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00536003
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

preterm delivery
preterm labor
perinatal morbidity
perinatal mortality

Study placed in the following topic categories:

Pregnancy Complications
Progesterone
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

Additional relevant MeSH terms:

Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009