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

Antiphospholipid Syndrome in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04274803
• Other study ID #: INTRALIPID-APS
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Antiphospholipid Syndrome in Pregnancy
• Pregnancy Complications
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Adel Elgergawy	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal loss	Fetal demise	within 9 months
Primary	Premature delivery	occurrence of preterm labour before 37 weeks	Before 37 weeks
Primary	Preeclampsia	Hypertesion, proteiuria and or edema	> 20 weeks
Primary	fetal growth restriction	Fetal poderal index less than normal	within 9 months