Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Jena
• Treatments: alpha-Tocopherol; Dalteparin; Folic Acid; Heparin; Heparin, Low-Molecular-Weight; Pyridoxine; Riboflavin; Thiamine; Tinzaparin; Tocopherols; Tocotrienols; Vitamin B 12; Vitamin B Complex; Vitamin E

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