Aspirine and/or low-molecular weight heparin for women with unexplained recurrent miscarriages and/or intra-uterine fetal death.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26868

Enrollment

300

Registered

2005-06-09

Start date

2004-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Placebo

2. Aspirin (carbasalate calcium)

3. Aspirin (carbasalate calcium)

4. Combined with low-molecular-weight heparin.

Eligibility

Inclusion criteria

Inclusion criteria: Women with at least 2 unexplained miscarriages and/or intra-uterine fetal deaths.

Exclusion criteria

Exclusion criteria: 1. Previous thromboembolism; 2. Antiphospholipid Syndrome (APLS); 3. Uterine abnormalities; 4. Patients’ or their partners’ abnormal karyotype; 5. Indication for anticoagulant treatment during pregnancy (for instance prostetic heart valves); 6. Metabolic and toxic factors (diabetes mellitus, radiation exposure); 7. Known erytrocyte antibody anti-P syndrome; 8. Pregnancy losses due to documented fetal malformation or the result of an infectious complication; 9. Known allergy to at least 3 different LMWH preparations; 10. Previous inclusion in the ALIFE trial (for another pregnancy).

Design outcomes

Primary

Measure	Time frame
Live birth rate.	—

Secondary

Measure	Time frame
1. Prevalence of adverse pregnancy outcomes: a. Preeclampsia; b. HELLP; c. Intrauterine growth retardation; d. Premature delivery; e. Congenital malformations prevalence of thromboembolic and hemorragic complications; f. Thrombocytopenia; g. Allergic reactions.	—

Contacts

Public ContactS. Middeldorp

Academic Medical Center (AMC), Department of Vascular Medicine, F4-276, P.O. Box 22660

alife@amc.uva.nl+31 (0)20 5665976

Outcome results