Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Study Overview
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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.

Official Title
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RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss

Conditions
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Recurrent Pregnancy Loss, Miscarriage

Intervention / Treatment
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* Drug: Hydroxychloroquine (HCQ)
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine (HCQ)<br>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. | Drug: Hydroxychloroquine (HCQ)<br> <br> * Other names: Plaquenil®;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth | Frequency of pregnancies resulting in live birth | Duration of gestation (up to 42 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Pregnancy Outcomes | Preterm birth, fetal growth restriction, stillbirth, placental insufficiency | Duration of gestation (up to 42 weeks) |