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

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

Study Overview

• Status: Withdrawn
• Conditions: Antiphospholipid Syndrome in Pregnancy
• Intervention / Treatment: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Conventional therapy of antiphospholipis 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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Adel Elgergawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intralipid group; 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; 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.
Active Comparator: Standard care group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: February 15, 2020
• First Submitted That Met QC Criteria: February 15, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Syndrome; Pregnancy Complications; Antiphospholipid Syndrome; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: INTRALIPID-APS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: when approved by ethical committee
• IPD Sharing Time Frame: 9 months
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No