Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT

Study Overview
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Brief Summary
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To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.

Detailed Description
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Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.

Official Title
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A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss

Conditions
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Recurrent Pregnancy Loss, Antiphospholipid Antibody Syndrome

Intervention / Treatment
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* Drug: Low molecular weight heparin and low dose aspirin
* Drug: Low dose aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of two or more unexplained consecutive pregnancy losses prior to 32 weeks presence of one of the panel of autoantibodies/thrombophilia markers confirmed pregnancy Exclusion Criteria: SLE known peptic ulcer disease sensitivity to ASA or heparin previous thrombotic event geographic distance from clinic failure to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a<br> | Drug: Low molecular weight heparin and low dose aspirin<br>* Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery<br>* Other names: ASA;|
| Active Comparator: b<br>Low dose aspirin only | Drug: Low dose aspirin<br>* 81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery<br>* Other names: ASA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. |  | Duration of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes included adverse events and incidence of bone loss in the two groups. |  | pre-pregnancy through postpartum period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial