NCT04274803

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antiphospholipid Syndrome in Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-02-18
• Last updated: 2021-06-14

Locations

1 site across 1 country: Egypt