Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 2

Conditions: Recurrent Pregnancy Loss; Miscarriage

Treatments: Drug: Placebo; Drug: Hydroxychloroquine (HCQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT02379650

78134

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Hydroxychloroquine (HCQ)

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine (HCQ)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo