Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
186 participants
INTERVENTIONAL
2018-01-25
2023-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Hydroxychloroquine
One tablet a day from inclusion until end of pregnancy or gestational age 28
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.
Hydroxychloroquine placebo
One tablet a day from inclusion until end of pregnancy or gestational age 28
Interventions
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Hydroxychloroquine
One tablet a day from inclusion until end of pregnancy or gestational age 28
Hydroxychloroquine placebo
One tablet a day from inclusion until end of pregnancy or gestational age 28
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
39 Years
FEMALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Henriette Svarre Nielsen, MD, DMSc
Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-004981-24
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HCQDenmark
Identifier Type: -
Identifier Source: org_study_id
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