Hydroxychloroquine and Unexplained Recurrent Miscarriage
Primary Purpose
Hydroxychloroquine
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydroxychloroquine
Folic Acid
Low-dose aspirin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hydroxychloroquine
Eligibility Criteria
Inclusion Criteria:
- Women had at least 2 previous miscarriage before 20 weeks.
- Women trying to conceive.
- No anatomical or endocrine cause of recurrent pregnancy loss.
- Women who have given their informed consent.
- The negative antibody test for antiphospholipid syndrome
Exclusion Criteria:
- Women who are already pregnant.
- Known contraindication to treatment by Hydroxychloroquine (
- Patients already using Hydroxychloroquine
- Impossible to follow-up.
Sites / Locations
- Abdel-rahman Mahmoud Mohammed
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
hydroxychloroquine group
Placebo group
Arm Description
hydroxychloroquine 400 mg preconceptional
will receive placebo
Outcomes
Primary Outcome Measures
Number of viable fetuses at 20 weeks gestation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04228263
Brief Title
Hydroxychloroquine and Unexplained Recurrent Miscarriage
Official Title
Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with both recurrent miscarriage and 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydroxychloroquine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine group
Arm Type
Other
Arm Description
hydroxychloroquine 400 mg preconceptional
Arm Title
Placebo group
Arm Type
Other
Arm Description
will receive placebo
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400mg
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
5 mg
Intervention Type
Drug
Intervention Name(s)
Low-dose aspirin
Intervention Description
75 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Number of viable fetuses at 20 weeks gestation
Time Frame
5 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women had at least 2 previous miscarriage before 20 weeks.
Women trying to conceive.
No anatomical or endocrine cause of recurrent pregnancy loss.
Women who have given their informed consent.
The negative antibody test for antiphospholipid syndrome
Exclusion Criteria:
Women who are already pregnant.
Known contraindication to treatment by Hydroxychloroquine (
Patients already using Hydroxychloroquine
Impossible to follow-up.
Facility Information:
Facility Name
Abdel-rahman Mahmoud Mohammed
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hydroxychloroquine and Unexplained Recurrent Miscarriage
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