Combining Aspirin and Hydroxychloroquine for High-Risk Pregnancies to Prevent 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
This study is testing if taking a combination of hydroxychloroquine and aspirin can help pregnant women at high risk for preeclampsia have healthier pregnancies compared to just taking aspirin alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 19 Years to 50 Years |
| Sex | Female |
| Sponsor | Chung-Ang University Hosptial, Chung-Ang University College of Medicine Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05287321 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label trial investigates the efficacy of a combination treatment of hydroxychloroquine and aspirin in singleton pregnancies at high risk for preeclampsia. Participants will be randomized to receive either hydroxychloroquine (200mg) with aspirin (100mg) daily or aspirin (100mg) alone, starting between 12 and 22 weeks of gestation and continuing until 36 weeks. The study aims to assess the impact of this treatment on pregnancy outcomes, particularly in women with a history of adverse pregnancy outcomes related to preeclampsia. Adherence to the medication regimen is required to be maintained at over 80%.
Who should consider this trial
Good fit: Ideal candidates are singleton pregnant women aged 19 to 50 with a history of preeclampsia, fetal growth restriction, or intrauterine fetal death.
Not a fit: Patients with severe underlying health conditions or major fetal malformations diagnosed early in pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of preeclampsia in high-risk pregnant women.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific combination is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The singleton pregnant women aged from 19 to 50 years 2. Includes at least one factors of the below ① History of preeclampsia ② History of fetal growth restriction ③ History of intrauterine fetal death 3. Women who have agreed to enroll in the study and given their informed consent Exclusion Criteria: 1. 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.) 2. Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies) 3. Major malformation of the fetus is diagnosed at 11-13 weeks of gestation 4. Elevated blood concentrations of creatinine more than double the normal value 5. Elevated blood concentrations of liver transaminases (AST(GOT) or ALT(GPT)) more than three times the normal value 6. 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 7. 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 8. Not suitable for participant based on medical evidence by investigator
Where this trial is running
Seoul
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Yoo-min Kim, MD — Chung-Ang University Gwangmyeong Hospital
- Study coordinator: Yoo-min Kim, MD
- Email: yoominkim@cau.ac.kr
- Phone: +82-2-6299-1661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.