Timing of Initiation of LMWH Administration in Pregnant Women With APS

Study Overview
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Brief Summary
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Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Detailed Description
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Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy

Official Title
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Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome

Conditions
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Recurrent Miscarriage, Antiphospholipid Syndrome

Intervention / Treatment
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* Drug: Enoxaparin
* Drug: Enoxaparin


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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Enoxaparin initiation<br>Women will start Enoxaparin therapy once positive pregnancy test is established | Drug: Enoxaparin<br>* Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy<br>* Other names: Clexan;|
| Active Comparator: Later Enoxaparin initiation<br>Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation | Drug: Enoxaparin<br>* Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy<br>* Other names: Clexan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women | After 12 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal loss | Unexplained fetal death of morphologically normal fetus after the first trimester | From 20 weeks to 42 weeks gestational age | 
| 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 |  | At birth | 

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