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Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400387
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
Ekkehard Schleussner, University of Jena

Brief Summary:
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 or disease Intervention/treatment Phase
Abortion, Habitual Drug: Fragmin P Forte (dalteparin sodium) Dietary Supplement: Multivitamin supplement Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss
Study Start Date : November 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Multivitamin supplement 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: 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

Primary Outcome Measures :
  1. ongoing intact pregnancy at 24 weeks of gestation [ Time Frame: at 24 weeks of gestation ]

Secondary Outcome Measures :
  1. 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 ]
  2. foetus with structural anomalies [ Time Frame: 6-8 weeks after delivery ]
  3. side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage) [ Time Frame: 6-8 weeks after delivery ]
  4. life birth [ Time Frame: 6-8 weeks after delivery ]
  5. preterm delivery (< 37 weeks of gestation) [ Time Frame: 6-8 weeks after delivery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400387

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Kinderwunschinstitut Schenk
Dobl, Austria, A-8143
Martin-Luther-Universität Halle Wittenberg
Halle/Saale, Sachsen-Anhalt, Germany, 06120
Universitätsfrauenklinik am Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, Germany, 01307
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
Halle / Saale, Germany, 06110
Medizinische Hochschule Hannover, Abt. für Gynäkologie und Geburtshilfe
Hannover, Germany, 30625
Frauenklinik Landshut Achdorf
Landshut, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Klinikum der Universität München Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Muenchen, Germany, 81377
Frauenklinik der Technischen Universität München, Klinikum rechts der Isa
Muenchen, Germany, 81675
Praxis für medizinische Genetik
Regensburg, Germany, 93047
Klinikum Stuttgart, Frauenklinik
Stuttgart, Germany, 70374
Universitätsfrauenklinik Tübingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University of Jena
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Principal Investigator: Ekkehard Schleussner, Prof. Dr. University of Jena, Hospital for gynaecology and obstetrics
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ekkehard Schleussner, Sponsor-Investigator, University of Jena Identifier: NCT00400387    
Other Study ID Numbers: EudraCT 2006-001984-53
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Ekkehard Schleussner, University of Jena:
recurrent pregnancy loss
Additional relevant MeSH terms:
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Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Vitamin B 12
Folic Acid
Vitamin B Complex
Vitamin E
Heparin, Low-Molecular-Weight
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Photosensitizing Agents
Dermatologic Agents
Protective Agents