Combining Aspirin and Hydroxychloroquine for High-Risk Pregnancies to Prevent Preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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%.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Role of Progesterone Membrane Receptors in Preeclampsia

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• Endothelial Biomarkers in Pregnancy: Endothelial Extracellular Vesicles and Hypertensive Disorders

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.