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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hydroxychloroquine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 11, 2020
Last Updated
July 21, 2021
Sponsor
Assiut University
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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

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Hydroxychloroquine and Unexplained Recurrent Miscarriage

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