Aspirin and/or low-molecular weight heparin for women with unexplained recurrent miscarriages and/or intra-uterine foetal death

Completed

Conditions: nexplained recurrent miscarriages, intra-uterine foetal death
Pregnancy and Childbirth
Spontaneous abortion

Registration Number: ISRCTN58496168

Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 300

Inclusion Criteria

Women with at least two unexplained miscarriages and/or intra-uterine foetal deaths

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 prosthetic heart valves)
6. Metabolic and toxic factors (diabetes mellitus, radiation exposure)
7. Known erythrocyte antibody anti-P syndrome
8. Pregnancy losses due to documented foetal malformation or the result of an infectious complication
9. Known allergy to at least three different low-molecular-weight heparin (LMWH) preparations
10. Previous inclusion in the ALIFE trial (for another pregnancy)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ive birth rate

Secondary Outcome Measures

Name	Time	Method
Prevalence of adverse pregnancy outcomes:<br>1. Pre-eclampsia<br>2. Haemolysis, elevated liver enzymes, low blood levels of platelets (HELLP) syndrome<br>3. Intra-uterine growth retardation<br>4. Premature delivery<br>5. Congenital malformations<br>6. Prevalence of thromboembolic and haemorragic complications<br>7. Thrombocytopaenia<br>8. Allergic reactions