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

NCT04274803 | Withdrawn Phase 4 DMC

• 1 other identifier: INTRALIPID-APS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antiphospholipid Syndrome in Pregnancy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Intralipid, 20% Intravenous Emulsion

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.

Drug: Conventional therapy of antiphospholipis syndrome

Interventions

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.

Intralipid group

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.

Standard care group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Adel Elgergawy

Tanta, 3111, Egypt

Location

MeSH Terms

Interventions

soybean oil, phospholipid emulsion

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 18, 2020
• Study Start: April 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 months

Locations

EG (1)