NCT05287321

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

The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia: a Multicenter, Open-label, Single Arm Trial, Investigator Initiated Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Yoo-min Kim · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 200mg with Aspirin 100mg

Timeline

• Start date: 2022-05-31
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-03-18
• Last updated: 2024-12-30

Locations

1 site across 1 country: South Korea