Hydroxychloroquine and Unexplained Recurrent Miscarriage

December 1, 2023 updated by: Abdelrahman Mahmoud Mohammed, Assiut University

Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Abdel-rahman Mahmoud Mohammed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria

  1. Women who are already pregnant.
  2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
  3. Patient already using HCQ
  4. Patient not get pregnant after 12 months of HCQ use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
Drug: Hydroxychloroquine
400mg
Drug: Folic Acid
5 mg
Drug: Low-dose aspirin
75 mg
Other: control group
not receive hydroxychloroquine
Drug: Folic Acid
5 mg
Drug: Low-dose aspirin
75 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of viable fetuses at 20 weeks gestation
Time Frame: 5 months
5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

July 8, 2023

Study Registration Dates

First Submitted

January 11, 2020

First Submitted That Met QC Criteria

January 11, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRP_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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