Status:
COMPLETED
Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss
Lead Sponsor:
University of Jena
Conditions:
Abortion, Habitual
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Detailed Description
Recurrent pregnancy loss (RPL) is a common health problem with three or more loses affecting 1-2% and two or more losses affecting up to 5% of women at the reproductive age (Brenner 2003). Several ae...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT00400387
Start Date
November 1 2006
End Date
April 1 2013
Last Update
September 17 2014
Active Locations (12)
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1
Kinderwunschinstitut Schenk
Dobl, Austria, A-8143
2
Martin-Luther-Universität Halle Wittenberg
Halle, Saxony-Anhalt, Germany, 06120
3
Universitätsfrauenklinik am Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, Germany, 01307
4
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
Halle, Germany, 06110