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

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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Recruitment Status : Withdrawn (no patient enrolled)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

Tracking Information
First Submitted Date  ICMJE February 15, 2020
First Posted Date  ICMJE February 18, 2020
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2020)
  • Fetal loss [ Time Frame: Allthrough pregnancy 9 month ]
    Fetal demise
  • Premature delivery [ Time Frame: Before 37 weeks ]
    occurrence of preterm labour before 37 weeks
  • Preeclampsia [ Time Frame: After 20 weeks till term ]
    Hypertesion, proteiuria and or edema
  • fetal growth restriction [ Time Frame: Allthrough prenancy 9 months ]
    Fetal poderal index less than normal
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Official Title  ICMJE Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Antiphospholipid Syndrome in Pregnancy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Intralipid, 20% Intravenous Emulsion
  • 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.
    Intervention: Drug: Conventional therapy of antiphospholipis syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2020)
105
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04274803
Other Study ID Numbers  ICMJE INTRALIPID-APS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: when approved by ethical committee
Supporting Materials: Study Protocol
Time Frame: 9 months
Responsible Party Ayman S Dawood, MD, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tanta University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP