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This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid group | Experimental | 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. |
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| Standard care group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid, 20% Intravenous Emulsion | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adel Elgergawy | Tanta | 3111 | Egypt |
when approved by ethical committee
9 months
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
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| Conventional therapy of antiphospholipis syndrome | Drug | 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. |
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