Recurrent Pregnancy Loss
Conditions
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.
Interventions
DRUGHydroxychloroquine
One tablet a day from inclusion until end of pregnancy or gestational age 28
One tablet a day from inclusion until end of pregnancy or gestational age 28
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth | At delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Birth weight | At delivery | — |
| Gestational age | up to at delivery | — |
| Admittance to neonatal unit | Within 28 days of delivery | — |
| Immunological status | Up to two years after end of study | Measuements of celllur and humoral immunity |
Countries
Denmark
Contacts
Primary ContactHenriette Svarre Nielsen, MD, DMSc
Backup ContactLouise Lunøe, Nurse
Outcome results
None listed