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

Tanta University

Status and phase: Withdrawn; Phase 4

Conditions: Antiphospholipid Syndrome in Pregnancy

Treatments: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Conventional therapy of antiphospholipis syndrome

Study type: Interventional

Funder types: Other

Identifiers

NCT04274803

INTRALIPID-APS

Details and patient eligibility

About

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

Full description

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.

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intralipid group

Experimental group

Description:

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.

Treatment:

Drug: Intralipid, 20% Intravenous Emulsion

Standard care group

Active Comparator group

Description:

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.

Treatment:

Drug: Conventional therapy of antiphospholipis syndrome