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Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

NCT02379650 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-08-12

No results posted yet for this study

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

DRUG

Hydroxychloroquine (HCQ)

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Robert Silver, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-07-31
Completion
2021-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02379650 on ClinicalTrials.gov