Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium
Overview
- Phase
- Phase 3
- Intervention
- Hydroxychloroquine
- Conditions
- Recurrent Pregnancy Loss
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Live birth
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Henriette Svarre Nielsen, MD, DMSc
Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor
Rigshospitalet, Denmark
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Hydroxychloroquine
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.
Intervention: Hydroxychloroquine placebo
Outcomes
Primary Outcomes
Live birth
Time Frame: At delivery
Secondary Outcomes
- Gestational age(up to 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(At delivery)
- Admittance to neonatal unit(Within 28 days of delivery)
- Birth weight(At delivery)
- Immunological status(Up to two years after end of study)