PreeclampsiaPhase 3HUGSNCT05287321
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
A Phase 3 study testing Hydroxychloroquine in people with Preeclampsia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg]) Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2022to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
- Previous inclusion in other intervention study within 3 months of screening (except for non-interventional 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, 06973
Yoo-min Kim, MD
About this study
Official title: 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 prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])
Read the detailed description
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%.
- Conditions
- Preeclampsia
- Being tested
- Hydroxychloroquine
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Hydroxychloroquine 200mg with Aspirin 100mg
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 100mg + Hydroxychloroquine 200mg | Experimental | Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite morbidity
Preeclampsia, Fetal growth restriction, Intrauterine fetal death, preterm delviery (<37weeks)
Measured: gestational period
Secondary outcomes (4)
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)
Measured: gestational period
early preterm birth
between 23+0wks and 33+6weeks
Measured: gestational period
Late preterm birth
delivery between 34+0 to 36+6 weeks
Measured: gestational period
Severe Fetal growh restrection
<3% and <5% for a given gestational age
Measured: gestational period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start31 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Oh Soo Young, Samsung Medical Center
- Investigators
- Yoo-min Kim, MD, Principal investigator, Chung-Ang University Gwangmyeong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287321
- Sponsor's protocol ID
- 2112-014-487
- Acronym
- HUGS
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YM, Seong J, Kim JH, Nam G, Kim GJ, Cha HH, Seong WJ, Sung JH, Choi SJ, Oh SY, Roh CR. Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study). BMJ Open. 2024 Dec 10;14(12):e081610. doi: 10.1136/bmjopen-2023-081610.
PubMed 39658277
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia: a Multicenter, Open-label, Single Arm Trial, Investigator Initiated Study
- ClinicalTrials.gov ID
- NCT05287321
- Acronym / sponsor ID
- HUGS / 2112-014-487
- Conditions
- Preeclampsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])
Detailed description
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirin 100mg + Hydroxychloroquine 200mg | Experimental | Drug: HydroxychloroquineAspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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.)
- Previous inclusion in other intervention study within 3 months of screening (except for non-interventional 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilHydroxychloroquine 200mg with Aspirin 100mg | Drug | Aspirin 100mg + Hydroxychloroquine 200mg |
Primary outcome
Composite morbidity
Time frame: gestational period
Preeclampsia, Fetal growth restriction, Intrauterine fetal death, preterm delviery (<37weeks)
4 secondary outcomes
Severe preeclampsia
Time frame: gestational period
early preterm birth
Time frame: gestational period
Late preterm birth
Time frame: gestational period
Severe Fetal growh restrection
Time frame: gestational period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 39658277Kim YM, Seong J, Kim JH, Nam G, Kim GJ, Cha HH, Seong WJ, Sung JH, Choi SJ, Oh SY, Roh CR. Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study). BMJ Open. 2024 Dec 10;14(12):e081610. doi: 10.1136/bmjopen-2023-081610.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoo-min Kim, MD principal investigator
Chung-Ang University Gwangmyeong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with Preeclampsia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoo-min Kim, MD (+82-2-6299-1661, yoominkim@cau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite morbidity (time frame: gestational period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.