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

NCT05287321 | Recruiting Phase 3

• 1 other identifier: 2112-014-487
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Composite morbidity

  Preeclampsia, Fetal growth restriction, Intrauterine fetal death, preterm delviery (\<37weeks)

  gestational period

Secondary Outcomes (4)

• Severe preeclampsia

  gestational period

• early preterm birth

  gestational period

• Late preterm birth

  gestational period

• Severe Fetal growh restrection

  gestational period

Study Arms (1)

Aspirin 100mg + Hydroxychloroquine 200mg

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 200mg with Aspirin 100mg

Also known as: Plaquenil

Aspirin 100mg + Hydroxychloroquine 200mg

Eligibility Criteria

• Age: 19 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

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

Study Sites (1)

Chung-Ang University Hospital

Seoul, 06973, South Korea

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yoo-min Kim, MD

  Chung-Ang University Gwangmyeong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoo-min Kim, MD

CONTACT

+82-2-6299-1661; yoominkim@cau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: May 31, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)