Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

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Rigshospitalet

Status and phase

Unknown
Phase 3

Conditions

Recurrent Pregnancy Loss

Treatments

Drug: Hydroxychloroquine
Drug: Hydroxychloroquine placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03305263
HCQDenmark
2016-004981-24 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

186 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

186 participants in 2 patient groups, including a placebo group

Hydroxychlorochine HCQ
Experimental group
Description:
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.
Treatment:
Drug: Hydroxychloroquine
Hydroxychlorochine HCQ Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Hydroxychloroquine placebo

Trial contacts and locations

0

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Central trial contact

Henriette Svarre Nielsen, MD, DMSc; Louise Lunøe, Nurse

Data sourced from clinicaltrials.gov

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