NCT02379650

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Pregnancy Loss
• Miscarriage

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine (HCQ)
DRUG	Placebo

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2021-07-01
• First posted: 2015-03-05
• Last updated: 2016-08-12

Locations

2 sites across 1 country: United States