Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

NCT ID: NCT02379650

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-07-31

Brief Summary

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Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.

Detailed Description

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Conditions

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Recurrent Pregnancy Loss Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxychloroquine (HCQ)

Subjects in the experimental arm will take 400 mg hydroxychloroquine pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over.

Group Type EXPERIMENTAL

Hydroxychloroquine (HCQ)

Intervention Type DRUG

Placebo

Subjects in the experimental arm will take placebo pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Hydroxychloroquine (HCQ)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Plaquenil®

Eligibility Criteria

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Inclusion Criteria

* Women ages 18 and older
* Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth

Exclusion Criteria

* Documented antiphospholipd antibodies
* Uterine malformation or parental chromosomal abnormality
* Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
* Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Robert Silver

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Silver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Intermountain Healthcare

Salt Lake City, Utah, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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78134

Identifier Type: -

Identifier Source: org_study_id

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