NCT05287321RecruitingPhase 3
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia: a Multicenter, Open-label, Single Arm Trial, Investigator Initiated Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group \[Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg\])
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 10 Mar 2022
- Start date
- 31 May 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Samsung Medical Center
- NCT number
- NCT05287321
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 58
- From 31 May 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies)
- 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
Other illness
- 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.)
Lab values
- 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 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
Other
- Major malformation of the fetus is diagnosed at 11-13 weeks of gestation
- Not suitable for participant based on medical evidence by investigator
Who the study is looking for
- 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
Age in the registry: 19 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.