Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
Overview
- Phase
- Not Applicable
- Intervention
- Hydroxychloroquine
- Conditions
- Unexplained Recurrent Miscarriage
- Sponsor
- Assiut University
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Number of viable fetuses at 20 weeks gestation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. 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.
Investigators
Abdelrahman Mahmoud Mohammed
Assistant Lecturer
Assiut University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
Intervention: Hydroxychloroquine
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
Intervention: Folic Acid
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
Intervention: Low-dose aspirin
control group
not receive hydroxychloroquine
Intervention: Folic Acid
control group
not receive hydroxychloroquine
Intervention: Low-dose aspirin
Outcomes
Primary Outcomes
Number of viable fetuses at 20 weeks gestation
Time Frame: 5 months
Secondary Outcomes
- Number of Preterm delivery before 37 week gestation.(8 months)
- Number of patients with miscarriage before 20 weeks(5 months)
- Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)(9 months)
- Number of fetus with Major congenital anmalies(9 months)
- Number of Live birth(9 months)