Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02379650

Enrollment

Registered

2015-03-05

Start date

2016-07-31

Completion date

2021-07-31

Last updated

2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Pregnancy Loss, Miscarriage

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.

Interventions

DRUGHydroxychloroquine (HCQ)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Live Birth	Duration of gestation (up to 42 weeks)	Frequency of pregnancies resulting in live birth

Secondary

Measure	Time frame	Description
Adverse Pregnancy Outcomes	Duration of gestation (up to 42 weeks)	Preterm birth, fetal growth restriction, stillbirth, placental insufficiency

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026