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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 31, 2021

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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 .

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tanta University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ayman S Dawood, MD, Lecturer – Tanta University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.