Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ekkehard Schleussner, University of Jena
ClinicalTrials.gov Identifier:
NCT00400387
First received: November 15, 2006
Last updated: September 16, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 449
Study Start Date: November 2006
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400387

Locations
Austria
Kinderwunschinstitut Schenk
Dobl, Austria, A-8143
Germany
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
Investigators
Principal Investigator: Ekkehard Schleussner, Prof. Dr. University of Jena, Hospital for gynaecology and obstetrics
  More Information

Additional Information:
No publications provided

Responsible Party: Ekkehard Schleussner, Sponsor-Investigator, 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: September 16, 2014
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
Tocopherols
Vitamin E
Alpha-Tocopherol
Tocotrienols
Dalteparin
Heparin, Low-Molecular-Weight
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014