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

Phase 4

Withdrawn

• Conditions: Antiphospholipid Syndrome in Pregnancy
• Interventions: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Conventional therapy of antiphospholipis syndrome

• Registration Number: NCT04274803
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-15
• Study First Submitted QC: 2020-02-15
• Study First Posted: 2020-02-18
• Study Start: 2020-04-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralipid group	Intralipid, 20% Intravenous Emulsion	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.
Standard care group	Conventional therapy of antiphospholipis syndrome	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Adel Elgergawy; 🇪🇬 Tanta, Egypt