Antiphospholipid Syndrome in Pregnancy
Conditions
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.
Interventions
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.
DRUGConventional 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal loss | within 9 months | Fetal demise |
| Premature delivery | Before 37 weeks | occurrence of preterm labour before 37 weeks |
| Preeclampsia | > 20 weeks | Hypertesion, proteiuria and or edema |
| fetal growth restriction | within 9 months | Fetal poderal index less than normal |
Countries
Egypt
Outcome results
None listed