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

Tanta University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Antiphospholipid Syndrome in Pregnancy

Interventions

Intralipid, 20% Intravenous EmulsionDRUG

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.

Conventional therapy of antiphospholipis syndromeDRUG

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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 .

Locations (1)

Adel Elgergawy

Tanta, Egypt

Outcomes

Primary Outcomes

Fetal loss

Fetal demise

Time frame: within 9 months

Premature delivery

occurrence of preterm labour before 37 weeks

Time frame: Before 37 weeks

Preeclampsia

Hypertesion, proteiuria and or edema

Time frame: > 20 weeks

fetal growth restriction

Fetal poderal index less than normal

Time frame: within 9 months

Data from ClinicalTrials.gov

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