Health TrialsbyHealthPanel

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

ConditionPreeclampsia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age19-50
SponsorYoo-min Kim

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The singleton pregnant women aged from 19 to 50 years

Includes at least one factors of the below

Women who have agreed to enroll in the study and given their informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Hydroxychloroquine

    Drug

    Hydroxychloroquine 200mg with Aspirin 100mg

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Aspirin 100mg + Hydroxychloroquine 200mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite morbidity

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

Time frame
gestational period

Secondary outcomes

1

Severe preeclampsia

with severe features: severe features are uncontrolled BP (systolic BP \> 160mm Hg or diastolic BP \> 110mm Hg on two occasions at least 4hours apart), persistent epigastric pain, new onset headaches, pulmonary edema, thrombocytopenia (platelet count \<100,000/µL), elevated liver enzymes (at twice the upper limit), impaired renal insufficiency (serum creatinine \> 1.1mg/dL)

Time frame
gestational period
2

early preterm birth

between 23+0wks and 33+6weeks

Time frame
gestational period
3

Late preterm birth

delivery between 34+0 to 36+6 weeks

Time frame
gestational period
4

Severe Fetal growh restrection

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

Time frame
gestational period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yoo-min Kim

Lead sponsor

Chung-Ang University Hospital

Sponsor institution

Ministry of Health & Welfare, Korea

Collaborator

Source ClinicalTrials.gov
Apply now