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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004981-24 | Other Grant/Funding Number | Regionernes Medicinpulje 15/1719 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychlorochine HCQ | Experimental | 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. |
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| Hydroxychlorochine HCQ Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | One tablet a day from inclusion until end of pregnancy or gestational age 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henriette Svarre Nielsen, MD, DMSc | Contact | +4535457515 | henriette.svarre.nielsen@regionh.dk | |
| Louise Lunøe, Nurse | Contact | +4535458486 | anne.louise.lunoee@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Hydroxychloroquine placebo | Drug | One tablet a day from inclusion until end of pregnancy or gestational age 28 |
|
| Gestational age | up to at delivery |
| Admittance to neonatal unit | Within 28 days of delivery |
| Immunological status | Measuements of celllur and humoral immunity | Up to two years after end of study |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |