Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious). There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy. This study has the potential to establish support for a new treatment option for unexplained RPL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
One tablet a day from inclusion until end of pregnancy or gestational age 28
One tablet a day from inclusion until end of pregnancy or gestational age 28
Rigshospitalet
Copenhagen, Denmark
RECRUITINGLive birth
Time frame: At delivery
Live birth after exclusion of patients with a chromosomal abnormal pregnancy loss, extrauterine pregnancy loss, intended abortion or patients with insufficient intake of study medicine
Time frame: At delivery
Birth weight
Time frame: At delivery
Gestational age
Time frame: up to at delivery
Admittance to neonatal unit
Time frame: Within 28 days of delivery
Immunological status
Measuements of celllur and humoral immunity
Time frame: Up to two years after end of study
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