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

Sponsor
Yoo-min Kim (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05287321
Collaborator
Ministry of Health & Welfare, Korea (Other)
122
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is prospective, randomised 1:1 open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg])

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study is prospective, randomised 1:1 open label, and multicenter trial (with two parallel-group [Hydroxychloroquine 200mg with Aspirin 100mg or 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

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia: a Multicenter, Open-label, Randomized Controlled Trial, Investigator Initiated Study
Anticipated Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Apr 15, 2024
Anticipated Study Completion Date :
Apr 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aspirin 100mg + Hydroxychloroquine 200mg

Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO

Drug: Hydroxychloroquine
Hydroxychloroquine 200mg with Aspirin 100mg
Other Names:
  • Plaquenil

    		•
    Active Comparator: Aspirin 100mg

    Aspirin 100mg 1T daily PO

    Drug: Hydroxychloroquine
    Hydroxychloroquine 200mg with Aspirin 100mg
    Other Names:
  • Plaquenil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite morbidity [37 weeks of gestational age]

      Preeclampsia, Fetal growth restriction, Intrauterine fetal death

    Secondary Outcome Measures

    1. Severe preeclampsia [37 weeks of gestational age]

      pregnant women have high blood pressure, protein in their urine, and swelling in their legs, feet, and hands

    2. Preterm delivery [37 weeks of gestational age]

      delivery before 37 weeks

    3. Late preterm birth [37 weeks of gestational age]

      delivery between 34+0 to 36+6 weeks

    4. Early preterm birth [37 weeks of gestational age]

      delivery between 23+0 to 33+6 weeks

    5. Severe Fetal growh restrection [37 weeks of gestational age]

      <3% and <5% for a given gestational age

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. 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

    1. Not suitable for participant based on medical evidence by investigator

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yoo-min Kim
    • Ministry of Health & Welfare, Korea

    Investigators

    • Principal Investigator: Yoo-min Kim, MD, Chung Ang University Hostpital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yoo-min Kim, Assistant professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    ClinicalTrials.gov Identifier:
    NCT05287321
    Other Study ID Numbers:
    • 2112-014-487
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Hydroxychloroquine

    Study Results

    No Results Posted as of Mar 18, 2022