Menu
Recruiting NCT05287321

The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia

Phase III Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydroxychloroquine.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: 19 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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%.

Interventions

  • Drug Hydroxychloroquine
    Hydroxychloroquine 200mg with Aspirin 100mg

Primary outcome measures

  • Composite morbidity [Time frame: gestational period]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Chung-Ang University Hospital — Seoul

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. PMID 39658277

Identifiers

NCT: NCT05287321 · 2112-014-487

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗