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Proton Pump Inhibitor

Metformin and Esomeprazole for Pre-eclampsia

Phase 4

Waitlist Available

Research Sponsored by Christiana Care Health Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months

Awards & highlights

Study Summary

This trial aims to improve the diagnosis and treatment of preterm preeclampsia. There are currently limited tests and treatments available for this condition. The study will investigate the effectiveness of Metformin

Who is the study for?

This trial is for pregnant individuals diagnosed with preterm preeclampsia, a condition characterized by high blood pressure and signs of damage to another organ system. The study aims to include those who need new treatment options and are willing to try Metformin or Esomeprazole.Check my eligibility

What is being tested?

The trial is testing the effectiveness of two medications, Metformin and Esomeprazole, in treating preterm preeclampsia. It also seeks to identify serum markers that could help diagnose this condition more accurately.See study design

What are the potential side effects?

Potential side effects from Metformin may include nausea, stomach upset, or diarrhea. Esomeprazole might cause symptoms like headache, dry mouth, abdominal pain, or constipation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean plasma difference in sFlt-1

Secondary outcome measures

Mean plasma difference in placental growth factor (PIGF)

Mean plasma difference in soluble endoglin (sEng)

Mean plasma difference in vascular endothelial growth factor (VEGF)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Metformin and EsomeprazoleExperimental Treatment2 Interventions

Patients diagnosed with preterm preeclampsia receive expectant management with additional metformin/esomeprazole.

Group II: No InterventionActive Control1 Intervention

Patients diagnosed with preterm preeclampsia receive expectant management only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esomeprazole

2008

Completed Phase 4

~2670

Metformin

2006

Completed Phase 4

~2430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Christiana Care Health ServicesLead Sponsor

115 Previous Clinical Trials

105,647 Total Patients Enrolled

Derek Bowden, MA,CIP,CHRCStudy DirectorChristianaCare Institutional Review Board

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do candidates below the age of 50 meet the criteria for participation in this study?

"The trial is seeking individuals above 18 years of age but below 60 years old to participate."

Answered by AI

Would it be possible for me to participate in this medical study?

"To qualify for enrollment, individuals must have a diagnosis of pre-eclampsia and be between 18 and 60 years old. A total of approximately four participants will be accepted into the study."

Answered by AI

Is the enrollment phase for this investigation currently ongoing?

"Information from clinicaltrials.gov indicates that although this study was posted on 2/11/2021 and updated most recently on 4/8/2024, it is not presently seeking new participants. However, there are currently 374 other trials actively enrolling individuals at this time."

Answered by AI

What are the potential risks associated with Metformin and Esomeprazole for individuals?

"Based on our evaluation, Metformin and Esomeprazole have been assigned a safety rating of 3 by our Power team. This decision is undergirded by the fact that this trial falls within Phase 4 where the treatment has already received regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin and Esomeprazole in Preterm Pre-eclampsia

Kendall Bielak, MD 2021. "Metformin and Esomeprazole in Preterm Pre-eclampsia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06359015.

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