Hydroxychloroquine and Unexplained Recurrent Miscarriage

Sponsor

Assiut University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04228263

Collaborator

(none)

156

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hydroxychloroquine	Drug: Hydroxychloroquine Drug: Folic Acid Drug: Low-dose aspirin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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: Placebo group will receive placebo	Drug: Folic Acid 5 mg Drug: Low-dose aspirin 75 mg Drug: Placebo oral tablet

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: Placebo group

will receive placebo

Drug: Folic Acid

5 mg

Drug: Low-dose aspirin

75 mg

Drug: Placebo

oral tablet

Outcome Measures

Primary Outcome Measures

Number of viable fetuses at 20 weeks gestation [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abdel-rahman Mahmoud Mohammed	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdelrahman Mahmoud Mohammed, Assistant Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT04228263

Other Study ID Numbers:

HRP_2020

First Posted:

Jan 14, 2020

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Abortion, Spontaneous

Study Results

No Results Posted as of Jul 22, 2021