Use of Warfarin After the First Trimester in Pregnant Women With APS

Study Overview
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Brief Summary
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Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Detailed Description
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Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.

Official Title
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Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome

Conditions
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Recurrent Miscarriage, Antiphospholipid Syndrome

Intervention / Treatment
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* Drug: Enoxaparin
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia Early pregnancy body weight is 50-90 Kg Exclusion Criteria: Women with systemic lupus erythematosus (SLE) Women with active thromboembolic disorders Women with history of previous thromboembolic disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enoxaparin group<br>Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy | Drug: Enoxaparin<br>* Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)<br>* Other names: Clexan;|
| Active Comparator: Warfarin group<br>Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester | Drug: Warfarin<br>* Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy<br>* Other names: Marevan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal loss | Unexplained fetal death of morphologically normal fetus after the first trimester | From 12 weeks to 42 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery | Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency | From 20 weeks to 34 weeks gestational age | 
| Intrauterine growth restriction (IUGR) | Birth weight less than the 10th percentile for gestational age | At birth | 
| Congenital fetal malformations | Congenital fetal malformations | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiphospholipid syndrome, APS, Warfarin