Preeclampsia
Conditions
Brief summary
Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 400 mg at start of pregnancy
DRUGFolic acid
5 mg
DRUGLow-dose aspirin
75 mg
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant women in 1st 6 weeks gestation. 2. History of preeclampsia in previous pregnancies. 3. Women who accepted to participate
Exclusion criteria
1. Risk factors (multiple gestation, chronic hypertension, chronic renal disease). 2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism 3. Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of cases of preeclampsia | 9 month |
Secondary
| Measure | Time frame |
|---|---|
| number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema | 9 month |
| Number of pregnancies with fetal malformation | 9 months |
| number of live birth | 9 months |
Countries
Egypt
Outcome results
None listed