A Phase 3 interventional study of Hydroxychloroquine in Preeclampsia, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])
This study is prospective, open label, and multicenter trial [Hydroxychloroquine 200mg with Aspirin 100mg]
The study population consists of the singleton pregnancy at high risk for preeclampsia who had adverse pregnancy outcome (preeclampsia or fetal growth restriction or intrauterine fetal death) in previous pregnancy.
After randomisation, participants are assigned to receive hydroxychloroquine 200mg with aspirin 100mg per day or aspirin 100mg per day. Treatment is initiated between 12 and 22 weeks' gestation and stopped at 36 weeks' gestation.
The medication adherence to dosing should be maintained at more than 80%.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 58 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Includes at least one factors of the below
① History of preeclampsia
② History of fetal growth restriction
③ History of intrauterine fetal death
Exclusion Criteria:
Conditions related with aspirin treatment
Conditions related with hydroxychloroquine treatment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO
Drug: Hydroxychloroquine
Hydroxychloroquine 200mg with Aspirin 100mg
Also known as: Plaquenil
Composite morbidity
Preeclampsia, Fetal growth restriction, Intrauterine fetal death, preterm delviery (\<37weeks)
Time frame: gestational period
Severe preeclampsia
with severe features: severe features are uncontrolled BP (systolic BP \> 160mm Hg or diastolic BP \> 110mm Hg on two occasions at least 4hours apart), persistent epigastric pain, new onset headaches, pulmonary edema, thrombocytopenia (platelet count \<100,000/µL), elevated liver enzymes (at twice the upper limit), impaired renal insufficiency (serum creatinine \> 1.1mg/dL)
Time frame: gestational period
early preterm birth
between 23+0wks and 33+6weeks
Time frame: gestational period
Late preterm birth
delivery between 34+0 to 36+6 weeks
Time frame: gestational period
Severe Fetal growh restrection
\<3% and \<5% for a given gestational age
Time frame: gestational period
Plan to share: No
Started May 2022 (actual). Primary completion is estimated for Dec 2027, 67 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Dec 2027, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Hydroxychloroquine