Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2015 |
| End Date: | March 2020 |
| Contact: | Karen Gibbins, MD |
| Email: | karen.gibbins@hsc.utah.edu |
| Phone: | (801) 585-8425 |
RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss
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.
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.
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
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