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Hydroxychloroquine and Unexplained Recurrent Miscarriage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228263
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Mahmoud Mohammed, Assiut University

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.

Condition or disease Intervention/treatment Phase
Hydroxychloroquine Drug: Hydroxychloroquine Drug: Folic Acid Drug: Low-dose aspirin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
Drug: Hydroxychloroquine
400mg

Drug: Folic Acid
5 mg

Drug: Low-dose aspirin
75 mg

Placebo group
will receive placebo
Drug: Folic Acid
5 mg

Drug: Low-dose aspirin
75 mg

Drug: Placebo
oral tablet




Primary Outcome Measures :
  1. Number of viable fetuses at 20 weeks gestation [ Time Frame: 5 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228263


Locations
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Egypt
Abdel-rahman Mahmoud Mohammed Recruiting
Assiut, Egypt, 71111
Contact: Abdel-rahman Mohammed, MSc    +201006374448    Abdoelkady4ever@gmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Abdelrahman Mahmoud Mohammed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04228263    
Other Study ID Numbers: HRP_2020
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Folic Acid
Hydroxychloroquine
Physiological Effects of Drugs
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents