Clinical trial NCT03305263: Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Official title: Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Recurrent Pregnancy Loss
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Live birth
timeFrame: At delivery
Secondary outcomes:
measure: 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
timeFrame: At delivery
measure: Birth weight
timeFrame: At delivery
measure: Gestational age
timeFrame: up to at delivery
measure: Admittance to neonatal unit
timeFrame: Within 28 days of delivery
measure: Immunological status
timeFrame: Up to two years after end of study
Other outcomes:
Locations:
city: København
country: Denmark
facility: Rigshospitalet
Study officials:
References: