Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?

Study Overview
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Brief Summary
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This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome

Detailed Description
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This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria. All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.

Official Title
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Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?

Conditions
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Antiphospholipid Syndrome in Pregnancy

Intervention / Treatment
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* Drug: Intralipid, 20% Intravenous Emulsion
* Drug: Conventional therapy of antiphospholipis syndrome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) . Exclusion Criteria: Patients with gestational age ≥ 9 weeks patients with diagnosed other auto-immune disorder patients with chronic hypertension, diabetes mellitus, thyroid disorders, patient with renal diseases patients who requested to withdraw from the study at any point .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intralipid group<br>the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. In addition intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy. | Drug: Intralipid, 20% Intravenous Emulsion<br>* intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.<br>|
| Active Comparator: Standard care group<br>the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. | Drug: Conventional therapy of antiphospholipis syndrome<br>* the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal loss | Fetal demise | within 9 months | 
| Premature delivery | occurrence of preterm labour before 37 weeks | Before 37 weeks | 
| Preeclampsia | Hypertesion, proteiuria and or edema | > 20 weeks | 
| fetal growth restriction | Fetal poderal index less than normal | within 9 months |