Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

  • STATUS
    Recruiting
  • End date
    Jan 24, 2023
  • participants needed
    186
  • sponsor
    Rigshospitalet, Denmark
Updated on 1 March 2022
malaria
discoid lupus erythematosus

Summary

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.

Details
Condition Recurrent Pregnancy Loss
Treatment hydroxychloroquine, Hydroxychloroquine Placebo
Clinical Study IdentifierNCT03305263
SponsorRigshospitalet, Denmark
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss

Exclusion Criteria

Age below 18 years or above 39 at inclusion
Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
Chromosomal abnormalities within the couple
Menstrual cycle below 23 days or above 35 days
Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein 25 mikrogr./l at repeated measurement with 12 weeks interval
HIV or Hepatitis B or C positive
Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
Hemoglobin 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion
Previous treatment with HCQ in pregnancy
>1previous live birth
previous participation in this trial
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