Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Phase 2

Withdrawn

• Conditions: Miscarriage; Recurrent Pregnancy Loss
• Interventions: Drug: Hydroxychloroquine (HCQ); Drug: Placebo

• Registration Number: NCT02379650
• Lead Sponsor: University of Utah

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-28
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Study Start: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-12
• Primary Completion: 2019-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine (HCQ)	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Live Birth	Duration of gestation (up to 42 weeks)	Frequency of pregnancies resulting in live birth

Secondary Outcome Measures

Name	Time	Method
Adverse Pregnancy Outcomes	Duration of gestation (up to 42 weeks)	Preterm birth, fetal growth restriction, stillbirth, placental insufficiency

Trial Locations

Locations (2)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States

Intermountain Healthcare; 🇺🇸 Salt Lake City, Utah, United States