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Proton Pump Inhibitor

Metformin + Esomeprazole for Preterm 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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean plasma difference in sFlt-1
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Metformin
2006
Completed Phase 4
~2430
Esomeprazole
2008
Completed Phase 4
~2670

Find a Location

Who is running the clinical trial?

Christiana Care Health ServicesLead Sponsor
116 Previous Clinical Trials
204,139 Total Patients Enrolled
Derek Bowden, MA,CIP,CHRCStudy DirectorChristianaCare Institutional Review Board
~0 spots leftby Jun 2025
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