Status:
UNKNOWN
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Recurrent Pregnancy Loss
Eligibility:
FEMALE
18-39 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03305263
Start Date
January 25 2018
End Date
January 1 2023
Last Update
March 12 2020
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100