Pregnant women with a history of recurrent pregnancy loss Pregnancy and Childbirth Pregnancy loss
Conditions
Interventions
Patients will be randomised between:
1. Dalteparin 5000 IE daily and multivitamin two tablets daily
2. Multivitamin two tablets daily
Treatment duration
Sponsors
Friedrich Schiller University Jena (Friedrich-Schiller-Universität Jena) (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Single pregnancy, fifth to eighth week of gestation 2. Documented foetal heart activity in UltraSound (US) 3. History of recurrent pregnancy loss, defined as: a. two or more early (less than 12 weeks of gestation) pregnancy losses, or b. one or more late (more than 12 weeks of gestation) pregnancy loss 4. Aged more than 18 years 5. Written informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. Previous pregnancy losses caused by foetal structural or chromosomal anomalies 2. Uterine anomalies 3. Maternal infection, which caused previous pregnancy loss 4. Risk group II or III according to EThIG study (Effectiveness of Thromboseprophylaxe as intervention in the Gravidität) risk stratification (clinical need for heparin prophylaxis) 5. Acute thromboembolic event (need of heparin therapy) 6. Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin 7. Anti-phospholipid antibody syndrome 8. Diabetes mellitus 9. Ongoing nicotine or drug or alcohol abuse 10. Human Immunodeficiency Virus (HIV) positive 11. Expected low compliance (e.g. by travel distance to trial site) 12. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing intact pregnancy at 24 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Live birth 2. Late pregnancy complication, defined as at least one of the following: a. preterm delivery (before 37 weeks of gestation) b. placenta insufficiency c. intrauterine growth restriction less than fifth percentile d. preeclampsia e. abruptio placentae 3. Foetus with structural anomalies 4. Symptomatic thromboembolic events 5. Side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage) | — |
Countries
Germany
Outcome results
None listed