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Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss
This study is currently recruiting participants.
Verified by University of Jena, February 2009
First Received: November 15, 2006   Last Updated: February 13, 2009   History of Changes
Sponsored by: University of Jena
Information provided by: University of Jena
ClinicalTrials.gov Identifier: NCT00400387
  Purpose

With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.


Condition Intervention Phase
Abortion, Habitual
 Drug: Fragmin P Forte (dalteparin)
Dietary Supplement: Multivitamin supplement
 Phase III

MedlinePlus related topics: Dietary Supplements
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • ongoing intact pregnancy at 24 weeks of gestation

Secondary Outcome Measures:
  • live birth
  • late pregnancy complication, defined as at least one of the following:
  • preterm delivery (before 37 weeks of gestation)
  • placenta insufficiency,
  • intrauterine growth restriction < 5. percentile,
  • preeclampsia
  • abruptio placentae
  • foetus with structural anomalies
  • symptomatic thromboembolic events
  • side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage)

Estimated Enrollment: 486
Study Start Date: November 2006
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: No Intervention
Multivitamin supplement only
Dietary Supplement: Multivitamin supplement
general pregnancy support by multivitamin supplementation and close monitoring
1: Experimental
Multivitamin supplement + dalteparin sodium
Drug: Fragmin P Forte (dalteparin)
subcutaneous injection, once daily supported by multivitamine supplement and close monitoring

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Single pregnancy, 5th to 8th week of gestation
  • Documented foetal heart activity in US

  • History of recurrent pregnancy loss, defined as:

    • 2 or more early (< 12 weeks of gestation) pregnancy losses or
    • 1 or more late (> 12 weeks of gestation) pregnancy loss
  • Age ³ 18 years
  • Written informed consent of the patient

Exclusion Criteria:

  • Previous pregnancy losses caused by foetal structural or chromosomal anomalies
  • Uterine anomalies
  • Maternal infection which caused previous pregnancy loss
  • Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis)
  • Acute thromboembolic event (need of heparin therapy)
  • Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin)
  • Antiphospholipid antibody syndrome
  • Diabetes mellitus
  • Ongoing nicotine or drug or alcohol abuse
  • Known HIV infection
  • Expected low compliance (e.g. by travel distance to trial site)
  • Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400387

Contacts
Contact: Ekkehard Scheussner, Prof. Dr. +49-3641-933190 ekkehard.schleussner@med.uni-jena.de
Contact: Petra Neuhaus, Dr. rer. nat +49-341-97 16255 petra.neuhaus@kksl.uni-leipzig.de

Locations
Austria
Kinderwunschinstitut Schenk Recruiting
Dobl, Austria, A-8143
Contact: Michael Schenk, MD         m.schenk@kinderwunsch-institut.at    
Contact: Ruth Illing, MD         Ruth.Illing@kinderwunsch-institut.at    
Germany
Universitätsfrauenklinik am Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
Contact: Gabriele Kamin, Dr. med.     +49 (0)351 458 2183     Gabriele.Kamin@uniklinikum-dresden.de    
Universitätsklinikum Gießen und Marburg, Standort Gießen, Interdisziplinärer Schwerpunkt Hämostaseologie Recruiting
Giessen, Germany, 35385
Contact: Bettina Kemkes-Matthes, Prof. Dr.     +49 (0)641 99 42720     Bettina.Kemkes-Matthes@innere.med.uni-giessen.de    
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Halle / Saale, Germany, 06110
Contact: Sven Seeger, OA Dr. med.     +49 (0)345 213 4341     s.seeger@krankenhaus-halle-saale.de    
Universitätsfrauenklinik Tübingen Recruiting
Tuebingen, Germany, 72076
Contact: Burkhard Schauf, PD Dr. med.     +49 (0)7071 298 6301     burkhard.schauf@med.uni-tuebingen.de    
Klinikum der Universität München Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Recruiting
Muenchen, Germany, 81377
Contact: Thaler, Prof. Dr.     +49 (0)89 7095 6821     Thaler@med.uni-muenchen.de    
Contact: Nina Rogenhofer, Dr. med.     +49 (0)89 7095 6821     nrogenho@med.uni-muenchen.de    
Sub-Investigator: Nina Rogenhofer, Dr. med.            
Frauenklinik der Technischen Universität München, Klinikum rechts der Isa Recruiting
Muenchen, Germany, 81675
Contact: Stepanie Pildner von Steinburg, Dr. med.     +49 (0)89 - 4140 2430     spvs@lrz.tum.de    
Medizinische Hochschule Hannover, Abt. für Gynäkologie und Geburtshilfe Recruiting
Hannover, Germany, 30625
Contact: Katrin Oehler, Dr. med.     +49 (0)511 532-6144     oehler.katrin@mh-hannover.de    
Sub-Investigator: Cordula Schippert, Dr. med.            
Sub-Investigator: Judith Schauer, Dr. med.            
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany
Contact: Michael Bohlmann, MD            
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe der LMU München - Innenstadt Recruiting
München, Germany
Contact: Maximilian Franz, MD            
Frauenklinik Landshut Achdorf Recruiting
Landshut, Germany
Contact: Thorsten Fischer     +49 (0) 871 - 404-2707        
Klinikum Stuttgart, Frauenklinik Recruiting
Stuttgart, Germany, 70374
Contact: Sylvia Ottmueller, MD         s.ottmueller@klinikum-stuttgart.de    
Praxis für medizinische Genetik Recruiting
93047 Regensburg, Germany, 93047
Contact: Susanne Ebner, MD         ebner@genetik-regensburg.de    
Germany, Bayern
Klinikum Nürnberg, Klinik für Frauenheilkunde / Schwerpunkt Geburtshilfe Recruiting
Nürnberg, Bayern, Germany, 90471
Contact: Meike von Have, MD         Meike.vonHave@klinikum-nuernberg.de    
Contact: Udo Schmalenbach, MD         Udo.Schmalenbach@klinikum-nuernberg.de    
Sub-Investigator: Elissabet Kourbanidou, MD            
Germany, Sachsen-Anhalt
Martin-Luther-Universität Halle Wittenberg Recruiting
Halle/Saale, Sachsen-Anhalt, Germany, 06120
Contact: Cerrie Scheler, MD     0345 557 2454        
Germany, Schleswig-Holstein
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Alexander Strauss, Prof. Dr.     0431 597 2118     astrauss@email.uni-kiel.de    
Contact: Andreas Schmutzler, MD     0431 597 2051     schmutzler@email.uni-kiel.de    
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Ekkehard Schleussner, Prof. Dr. University of Jena, Hospital for gynaecology and obstetrics
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Jena ( Prof. Dr. Ekkehard Schleussner )
Study ID Numbers: EudraCT 2006-001984-53
Study First Received: November 15, 2006
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00400387     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Austria: Agency for Health and Food Safety

Keywords provided by University of Jena:
recurrent pregnancy loss

Study placed in the following topic categories:
Fibrin Modulating Agents
Anticoagulants
Pregnancy Complications
Dalteparin
Abortion, Habitual
 Fibrinolytic Agents
Cardiovascular Agents
Abortion, Spontaneous
Recurrence

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Dalteparin
Therapeutic Uses
 Hematologic Agents
Abortion, Habitual
Fibrinolytic Agents
Cardiovascular Agents
Abortion, Spontaneous
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009



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