Can a malaria drug help prevent preeclampsia?
NCT ID NCT05287321
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding hydroxychloroquine to daily aspirin reduces the risk of preeclampsia in pregnant women with a history of the condition, fetal growth restriction, or stillbirth. Participants receive either aspirin alone or aspirin plus hydroxychloroquine throughout pregnancy. Researchers track outcomes like preeclampsia, preterm birth, and fetal growth to see if the combination offers better protection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hydroxychloroquine combined with aspirin
- What this could lead to
- If it works, this combination could offer a new way to prevent preeclampsia and related complications in pregnant women at high risk.
- What could go wrong
- The trial is small and open-label, so results may be less reliable. Hydroxychloroquine also carries risks in pregnancy, and the benefit over aspirin alone is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chung-Ang University Hospital
RECRUITINGSeoul, 06973, South Korea
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Other studies related to the condition(s) this trial covers.
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- Can a neck ultrasound predict fluid balance in preeclampsia?
- Can a higher aspirin dose shield High-Risk pregnancies from preeclampsia?