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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])
This study is prospective, open label, and multicenter trial [Hydroxychloroquine 200mg with Aspirin 100mg]
The study population consists of the singleton pregnancy at high risk for preeclampsia who had adverse pregnancy outcome (preeclampsia or fetal growth restriction or intrauterine fetal death) in previous pregnancy.
After randomisation, participants are assigned to receive hydroxychloroquine 200mg with aspirin 100mg per day or aspirin 100mg per day. Treatment is initiated between 12 and 22 weeks' gestation and stopped at 36 weeks' gestation.
The medication adherence to dosing should be maintained at more than 80%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin 100mg + Hydroxychloroquine 200mg | Experimental | Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine 200mg with Aspirin 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite morbidity | Preeclampsia, Fetal growth restriction, Intrauterine fetal death, preterm delviery (<37weeks) | gestational period |
| Measure | Description | Time Frame |
|---|---|---|
| Severe preeclampsia | with severe features: severe features are uncontrolled BP (systolic BP > 160mm Hg or diastolic BP > 110mm Hg on two occasions at least 4hours apart), persistent epigastric pain, new onset headaches, pulmonary edema, thrombocytopenia (platelet count <100,000/µL), elevated liver enzymes (at twice the upper limit), impaired renal insufficiency (serum creatinine > 1.1mg/dL) | gestational period |
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Inclusion Criteria:
The singleton pregnant women aged from 19 to 50 years
Includes at least one factors of the below
â‘ History of preeclampsia
â‘¡ History of fetal growth restriction
â‘¢ History of intrauterine fetal death
Women who have agreed to enroll in the study and given their informed consent
Exclusion Criteria:
Indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignancy (However, the participation of the trial is allowed by the investigator based on medically necessary.)
Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies)
Major malformation of the fetus is diagnosed at 11-13 weeks of gestation
Elevated blood concentrations of creatinine more than double the normal value
Elevated blood concentrations of liver transaminases (AST(GOT) or ALT(GPT)) more than three times the normal value
Conditions related with aspirin treatment
Conditions related with hydroxychloroquine treatment
Not suitable for participant based on medical evidence by investigator
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoo-min Kim, MD | Contact | +82-2-6299-1661 | yoominkim@cau.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yoo-min Kim, MD | Chung-Ang University Gwangmyeong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Recruiting | Seoul | 06973 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39658277 | Derived | Kim YM, Seong J, Kim JH, Nam G, Kim GJ, Cha HH, Seong WJ, Sung JH, Choi SJ, Oh SY, Roh CR. Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study). BMJ Open. 2024 Dec 10;14(12):e081610. doi: 10.1136/bmjopen-2023-081610. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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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| early preterm birth | between 23+0wks and 33+6weeks | gestational period |
| Late preterm birth | delivery between 34+0 to 36+6 weeks | gestational period |
| Severe Fetal growh restrection | <3% and <5% for a given gestational age | gestational period |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |