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Clinical Trials/NCT04228263
NCT04228263
Completed
Not Applicable

Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage

Assiut University1 site in 1 country156 target enrollmentJanuary 1, 2020

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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