Hydroxychloroquine and Unexplained Recurrent Miscarriage

Not Applicable

Completed

• Conditions: Unexplained Recurrent Miscarriage
• Interventions: Drug: Hydroxychloroquine; Drug: Low-dose aspirin; Drug: Folic Acid

• Registration Number: NCT04228263
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-11
• Study First Submitted QC: 2020-01-11
• Study First Posted: 2020-01-14
• Primary Completion: 2023-03-10
• Study Completion: 2023-07-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Low-dose aspirin	not receive hydroxychloroquine
hydroxychloroquine group	Low-dose aspirin	hydroxychloroquine 400 mg preconceptional
hydroxychloroquine group	Hydroxychloroquine	hydroxychloroquine 400 mg preconceptional
hydroxychloroquine group	Folic Acid	hydroxychloroquine 400 mg preconceptional
control group	Folic Acid	not receive hydroxychloroquine

Primary Outcome Measures

Name	Time	Method
Number of viable fetuses at 20 weeks gestation	5 months

Secondary Outcome Measures

Name	Time	Method
Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)	9 months
Number of Preterm delivery before 37 week gestation.	8 months
Number of patients with miscarriage before 20 weeks	5 months
Number of fetus with Major congenital anmalies	9 months
Number of Live birth	9 months

Trial Locations

Locations (1)

Abdel-rahman Mahmoud Mohammed; 🇪🇬 Assiut, Egypt