Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

NCT02379650 | Withdrawn Phase 2 DMC

• 1 other identifier: 78134
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Live Birth

  Frequency of pregnancies resulting in live birth

  Duration of gestation (up to 42 weeks)

Secondary Outcomes (1)

• Adverse Pregnancy Outcomes

  Duration of gestation (up to 42 weeks)

Study Arms (2)

Hydroxychloroquine (HCQ)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Hydroxychloroquine (HCQ) DRUG

Also known as: Plaquenil®

Hydroxychloroquine (HCQ)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (2)

Intermountain Healthcare

Salt Lake City, Utah, 84107, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert Silver, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: March 5, 2015
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2021
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

US (2)