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

Primary Purpose

Preeclampsia

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
Yoo-min Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Ang University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aspirin 100mg + Hydroxychloroquine 200mg

Arm Description

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

Outcomes

Primary Outcome Measures

Composite morbidity
Preeclampsia, Fetal growth restriction, Intrauterine fetal death

Secondary Outcome Measures

Severe preeclampsia
pregnant women have high blood pressure, protein in their urine, and swelling in their legs, feet, and hands
Preterm delivery
delivery before 37 weeks
Late preterm birth
delivery between 34+0 to 36+6 weeks
Early preterm birth
delivery between 23+0 to 33+6 weeks
Severe Fetal growh restrection
<3% and <5% for a given gestational age

Full Information

First Posted
March 10, 2022
Last Updated
May 3, 2023
Sponsor
Yoo-min Kim
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05287321
Brief Title
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Acronym
HUGS
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yoo-min Kim
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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])
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin 100mg + Hydroxychloroquine 200mg
Arm Type
Experimental
Arm Description
Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxychloroquine 200mg with Aspirin 100mg
Primary Outcome Measure Information:
Title
Composite morbidity
Description
Preeclampsia, Fetal growth restriction, Intrauterine fetal death
Time Frame
gestational period
Secondary Outcome Measure Information:
Title
Severe preeclampsia
Description
pregnant women have high blood pressure, protein in their urine, and swelling in their legs, feet, and hands
Time Frame
37 weeks of gestational age
Title
Preterm delivery
Description
delivery before 37 weeks
Time Frame
37 weeks of gestational age
Title
Late preterm birth
Description
delivery between 34+0 to 36+6 weeks
Time Frame
37 weeks of gestational age
Title
Early preterm birth
Description
delivery between 23+0 to 33+6 weeks
Time Frame
37 weeks of gestational age
Title
Severe Fetal growh restrection
Description
<3% and <5% for a given gestational age
Time Frame
37 weeks of gestational age

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoo-min Kim, MD
Phone
+82-2-6299-1661
Email
yoominkim@cau.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoo-min Kim, MD
Organizational Affiliation
Chung-Ang University Gwangmyeong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo-min Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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