A Phase 3 interventional study of Hydroxychloroquine and Hydroxychloroquine placebo in Recurrent Pregnancy Loss, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Rigshospitalet, Denmark · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Women in the experimental arm will take 200 mg HCQ tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
Drug: Hydroxychloroquine
Women in the experimental arm will take 200 mg HCQ placebo tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
Drug: Hydroxychloroquine placebo
One tablet a day from inclusion until end of pregnancy or gestational age 28
Also known as: Placebo
One tablet a day from inclusion until end of pregnancy or gestational age 28
Live 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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark