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Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Jena.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00400387
First received: November 15, 2006
Last updated: August 3, 2010
Last verified: February 2009
History of Changes
  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 sodium)
Dietary Supplement: Multivitamin supplement
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • ongoing intact pregnancy at 24 weeks of gestation [ Time Frame: at 24 weeks of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • late pregnancy complication, defined as at least one of the following: preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]
  • foetus with structural anomalies [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]
  • side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage) [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: Yes ]
  • life birth [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]
  • preterm delivery (< 37 weeks of gestation) [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]

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
No Intervention: 2
Multivitamin supplement only
 Dietary Supplement: Multivitamin supplement
general pregnancy support by multivitamin supplementation and close monitoring
Other Names:
  • Femibion 800 Folsäure plus Metafolin:
  • Ascorbinsäure 110 mg
  • Nicotinamid 15 mg
  • alpha-Tocopherol acetat 13 mg
  • RRR-alpha-Tocopherol Äquivalent 7.93 mg
  • Pantothensäure 6 mg
  • Pyridoxin 1.9 mg
  • Riboflavin 1.6 mg
  • Thiamin 1.2 mg
  • olsäure 0.4 mg
  • Biotin 0.06 mg
  • Cyanocobalamin 0.0035 mg
  • Calcium mefolinat
  • Folsäure 0.4 mg
  • Kalium iodid
  • Iodid Ion 0.15 mg
Experimental: 1
Multivitamin supplement + dalteparin sodium
 Drug: Fragmin P Forte (dalteparin sodium)
subcutaneous injection, once daily supported by multivitamine supplement and close monitoring
Other Name: low molecular weight heparin

  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
  • at least 18 years of age
  • 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
Martin-Luther-Universität Halle Wittenberg Recruiting
Halle/Saale, Sachsen-Anhalt, Germany, 06120
Contact: Cerrie Scheler, MD     0345 557 2454        
Praxis für medizinische Genetik Recruiting
93047 Regensburg, Germany, 93047
Contact: Susanne Ebner, MD         ebner@genetik-regensburg.de    
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    
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    
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.            
Principal Investigator: Susanne Grüssner, PD Dr. med.            
Frauenklinik Landshut Achdorf Recruiting
Landshut, Germany
Contact: Thorsten Fischer     +49 (0) 871 - 404-2707        
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany
Contact: Michael Bohlmann, MD            
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    
Klinikum Stuttgart, Frauenklinik Recruiting
Stuttgart, Germany, 70374
Contact: Sylvia Ottmueller, MD         s.ottmueller@klinikum-stuttgart.de    
Universitätsfrauenklinik Tübingen Recruiting
Tuebingen, Germany, 72076
Contact: Melanie Henes, Dr. med.     +49 (0)7071 298 6301     Melanie.Henes@med.uni-tuebingen.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: Prof. Dr. Ekkehard Schleussner, University of Jena
ClinicalTrials.gov Identifier: NCT00400387     History of Changes
Other Study ID Numbers: EudraCT 2006-001984-53
Study First Received: November 15, 2006
Last Updated: August 3, 2010
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

Additional relevant MeSH terms:
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Heparin, Low-Molecular-Weight
Dalteparin
Vitamin B 12
Alpha-Tocopherol
Vitamin E
Tocopherols
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013