Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Recurrent Pregnancy Loss, Miscarriage

In brief

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.

Key facts

Study ID

NCT02379650

Run by

University of Utah

People needed

0

Starts

2016-07-01

Expected to finish

2021-07-01

Last updated by the study team

2016-08-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Intermountain Healthcare — Salt Lake City, Utah, United States
• University of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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