Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Miscarriage Clinical Trial

Official title:

RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02379650
• Other study ID #: 78134
• Status: Withdrawn
• Phase: Phase 2
• First received: February 28, 2015
• Last updated: August 10, 2016
• Start date: July 2016
• Est. completion date: July 2021

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• Miscarriage
• Recurrent Pregnancy Loss

Intervention

Drug:
• Hydroxychloroquine (HCQ)

• Placebo

Locations

Country	Name	City	State
United States	Intermountain Healthcare	Salt Lake City	Utah
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth	Frequency of pregnancies resulting in live birth	Duration of gestation (up to 42 weeks)	No
Secondary	Adverse Pregnancy Outcomes	Preterm birth, fetal growth restriction, stillbirth, placental insufficiency	Duration of gestation (up to 42 weeks)	No