Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Overview

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.

Full Title of Study: “Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) – et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2022

Interventions

  • Drug: Hydroxychloroquine
    • One tablet a day from inclusion until end of pregnancy or gestational age 28
  • Drug: Hydroxychloroquine placebo
    • One tablet a day from inclusion until end of pregnancy or gestational age 28

Arms, Groups and Cohorts

  • Experimental: Hydroxychlorochine HCQ
    • 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.
  • Placebo Comparator: Hydroxychlorochine HCQ Placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Live birth
    • Time Frame: At delivery

Secondary Measures

  • 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
    • Time Frame: Up to two years after end of study
    • Measuements of celllur and humoral immunity

Participating in This Clinical Trial

Inclusion Criteria

1. ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL 2. ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss. Exclusion Criteria:

1. Age below 18 years or above 39 at inclusion 2. Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography 3. Chromosomal abnormalities within the couple 4. Menstrual cycle below 23 days or above 35 days 5. 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. 6. HIV or Hepatitis B or C positive 7. Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ) 8. Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents 9. Hemoglobin ≤ 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion 10. Previous treatment with HCQ in pregnancy 11. >1previous live birth 12. previous participation in this trial

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Henriette Svarre Nielsen, MD, DMSc, Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor – Rigshospitalet, Denmark
  • Overall Contact(s)
    • Henriette Svarre Nielsen, MD, DMSc, +4535457515, henriette.svarre.nielsen@regionh.dk

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