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Tests treatment safety and results for Preeclampsia
Official title The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
ClinicalTrials.gov ID: NCT05287321
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, being studied as a potential treatment for preeclampsia.
Also referred to as Plaquenil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 50, women only
You may be able to join if
- The singleton pregnant women aged from 19 to 50 years
- Includes at least one factors of the below ① History of preeclampsia ② History of fetal growth restriction ③ History of intrauterine fetal death
- Women who have agreed to enroll in the study and given their informed consent
You likely can't join if
- Indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary...
- Previous inclusion in other intervention study within 3 months of screening (except for non-treatment 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
See the full eligibility criteria
- The singleton pregnant women aged from 19 to 50 years
- Includes at least one factors of the below ① History of preeclampsia ② History of fetal growth restriction ③ History of intrauterine fetal death
- Women who have agreed to enroll in the study and given their informed consent
- 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...
- Previous inclusion in other intervention study within 3 months of screening (except for non-treatment 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
- Previous exposure within 28 days of screening
- Previous NSAID exposure within 28 days of screening
- Bleeding disorder (von Willebrand's disease, peptic ulceration)
- Hypersensitivity to aspirin
- Conditions related with hydroxychloroquine treatment
- Previous exposure within 28 days of screening
- Hypersensitivity to hydroxychloroquine and 4-aminoquinoline compounds
- Maculopathy
- Medications that has potential for visual disturbance
- Women who have potential for changes in the retina or visual impairment by 4-aminoquinoline compounds
- Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Prolonged QT interval on EKG (congenital or acquired) or The risk factors of QT prolongation (heart failure, arrhythmia, myocardial ischemia)
- Low level of potassium in the blood
- Low level of magnesium in the blood
- Not suitable for participant based on medical evidence by investigator
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.