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Metformin + Esomeprazole for Pre-eclampsia

Phase 1

Waitlist Available

Led By Matthew Hoffman, MD, MPH

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

Women with pre-eclampsia superimposed on chronic hypertension

Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of delivery

Awards & highlights

Study Summary

This trial found that extended release metformin can prolong gestation in women with preterm pre-eclampsia, and that combination metformin and esomeprazole has shown promise in the treatment of preeclampsia.

Who is the study for?

This trial is for women over 18 with preterm pre-eclampsia between 24 and almost 32 weeks of pregnancy, carrying a single baby without major anomalies. It's not for those likely to deliver within 48 hours, with immediate delivery needs due to maternal or fetal issues, diabetes on metformin therapy, contraindications to the drugs being tested, certain kidney function levels, using interacting medications, multiple pregnancies, metabolic acidosis or allergies to the drugs.Check my eligibility

What is being tested?

The study tests if Esomeprazole (20mg) combined with extended release Metformin can help prolong pregnancy in women with preterm pre-eclampsia. This follows evidence that both drugs may reduce harmful substances from the placenta and improve blood vessel function.See study design

What are the potential side effects?

Potential side effects include digestive issues like nausea and diarrhea from Metformin; Esomeprazole might cause headaches or stomach pain. Both could potentially affect liver enzymes or vitamin B12 levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with worsening high blood pressure during pregnancy.

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I have pre-eclampsia and am between 24 and 32 weeks pregnant with one healthy baby.

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I have been diagnosed with preeclampsia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of delivery 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 from randomization to day 7

Secondary outcome measures

Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs

Gestational age at delivery

Maternal death

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: combination metformin and esomeprazoleExperimental Treatment1 Intervention

Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.

Group II: expectant managementActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esomeprazole 20mg

2022

Completed Phase 4

~990

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Christiana Care Health ServicesLead Sponsor

114 Previous Clinical Trials

105,613 Total Patients Enrolled

Matthew Hoffman, MD, MPHPrincipal InvestigatorChristianaCare

Media Library

Metformin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05232994 — Phase 1

Preterm Birth Research Study Groups: combination metformin and esomeprazole, expectant management

Preterm Birth Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05232994 — Phase 1

Metformin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232994 — Phase 1

Frequently Asked Questions

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

Is this research project accepting participants at the present moment?

"The details on clinicaltrials.gov does not indicate that the study is recruiting patients at this moment in time; having been initially posted December 1st 2022 and last edited November 2nd 2022. Notwithstanding, there are currently 341 trials seeking participants."

Answered by AI

Can individuals aged 70 and above participate in this experiment?

"According to the trial's inclusion criteria, eligible participants must be between 18-55 years old. Additionally, there are 193 trials for minors and 118 for elderly patients."

Answered by AI

Has the FDA sanctioned Esomeprazole 20mg for public consumption?

"Due to the nature of this phase 1 clinical trial, our team at Power assigned esomeprazole 20mg a score of 1 on safety and efficacy."

Answered by AI

Who is eligible to register for this research endeavor?

"This clinical trial is in search of 38 women aged 18-55 who are currently afflicted with preeclampsia during their second trimester. To be accepted, applicants must have pre-eclampsia between 24+0 and 31+6 weeks gestation with a viable single fetus, as well as no major anomalies. Additionally, they must present with pre-eclampsia superimposed on chronic hypertension and be candidates for expectant management without an immediate need for delivery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin and Esomeprazole For Preterm Pre-eclampsia

2023. "Metformin and Esomeprazole For Preterm Pre-eclampsia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05232994.

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