Back to resultsDose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Primary Purpose
Antiphospholipid Syndrome in Pregnancy
Status
Withdrawn
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Intralipid, 20% Intravenous Emulsion
Conventional therapy of antiphospholipis syndrome
Sponsored by
About this trial
This is an interventional treatment trial for Antiphospholipid Syndrome in Pregnancy
Eligibility 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 .
Sites / Locations
- Adel Elgergawy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intralipid group
Standard care group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Fetal loss
Fetal demise
Premature delivery
occurrence of preterm labour before 37 weeks
Preeclampsia
Hypertesion, proteiuria and or edema
fetal growth restriction
Fetal poderal index less than normal
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04274803
Brief Title
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Official Title
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no patient enrolled
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intralipid group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Intralipid, 20% Intravenous Emulsion
Intervention Description
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 Type
Drug
Intervention Name(s)
Conventional therapy of antiphospholipis syndrome
Intervention Description
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 Measure Information:
Title
Fetal loss
Description
Fetal demise
Time Frame
within 9 months
Title
Premature delivery
Description
occurrence of preterm labour before 37 weeks
Time Frame
Before 37 weeks
Title
Preeclampsia
Description
Hypertesion, proteiuria and or edema
Time Frame
> 20 weeks
Title
fetal growth restriction
Description
Fetal poderal index less than normal
Time Frame
within 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Facility Information:
Facility Name
Adel Elgergawy
City
Tanta
ZIP/Postal Code
3111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
when approved by ethical committee
IPD Sharing Time Frame
9 months
Learn more about this trial
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
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