Actively Recruiting
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Led by Yoo-min Kim · Updated on 2024-12-30
58
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
Y
Yoo-min Kim
Lead Sponsor
M
Ministry of Health & Welfare, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group \[Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg\])
CONDITIONS
Official Title
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 19 to 50 years with a singleton pregnancy
- History of preeclampsia, fetal growth restriction, or intrauterine fetal death in a previous pregnancy
- Willingness to participate and provide informed consent
You will not qualify if you...
- Severe cardiovascular, immune, respiratory, gastrointestinal/liver, biliary, kidney, urinary, nervous, musculoskeletal, psychiatric, infectious diseases, or malignancy unless approved by investigator
- Participation in another interventional study within 3 months before screening (non-interventional studies allowed)
- Major fetal malformation diagnosed between 11 and 13 weeks of pregnancy
- Blood creatinine levels more than twice the normal value
- Liver transaminases (AST or ALT) levels more than three times the normal value
- Recent exposure (within 28 days) to aspirin or NSAIDs, bleeding disorders, or aspirin hypersensitivity
- Recent exposure (within 28 days) to hydroxychloroquine, hypersensitivity to hydroxychloroquine or related compounds, maculopathy, visual disturbance risks, galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Prolonged QT interval on EKG or risk factors for QT prolongation
- Low blood potassium or magnesium levels
- Determined unsuitable for participation by investigator based on medical evidence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chung-Ang University Hospital
Seoul, South Korea, 06973
Actively Recruiting
Research Team
Y
Yoo-min Kim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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