Actively Recruiting

Phase 3
Age: 19Years - 50Years
FEMALE
NCT05287321

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

Age: 19Years - 50Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Chung-Ang University Hospital

Seoul, South Korea, 06973

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here