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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04274803
Recruitment Status : Withdrawn (no patient enrolled)
First Posted : February 18, 2020
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

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

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome in Pregnancy Drug: Intralipid, 20% Intravenous Emulsion Drug: Conventional therapy of antiphospholipis syndrome Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Fetal loss [ Time Frame: within 9 months ]
    Fetal demise

  2. Premature delivery [ Time Frame: Before 37 weeks ]
    occurrence of preterm labour before 37 weeks

  3. Preeclampsia [ Time Frame: > 20 weeks ]
    Hypertesion, proteiuria and or edema

  4. fetal growth restriction [ Time Frame: within 9 months ]
    Fetal poderal index less than normal



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274803


Locations
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Egypt
Adel Elgergawy
Tanta, Egypt, 3111
Sponsors and Collaborators
Tanta University
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Responsible Party: Ayman S Dawood, MD, Lecturer, Tanta University
ClinicalTrials.gov Identifier: NCT04274803    
Other Study ID Numbers: INTRALIPID-APS
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: when approved by ethical committee
Supporting Materials: Study Protocol
Time Frame: 9 months

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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
Additional relevant MeSH terms:
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Pregnancy Complications
Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions