Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)

Status Completed

Clinical Trial Summary

Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the hematological system, the cardiovascular system and the feto-placental unit. In its most severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and even death.

Clinical Trial Description

The key aspects in the pathophysiology of pre-eclampsia are placental oxidative stress (and hypoxia), placental release of the anti-angiogenic factors Soluble Fms Like Tyrosine Kinase -1 and soluble endoglin and maternal endothelial dysfunction. A drug that can counter these pathological steps could be a strategy to treat pre-eclampsia. If an affordable and safe treatment was available it could temporize the disease progression of pre-eclampsia thereby delaying delivery to gain gestation. This could save the lives of many infants and decrease the hospital burden caused by iatrogenic prematurity. Currently, there are trials investigating the possible use of pravastatin to treat pre-eclampsia, and to prevent it There are no other significant trials of orally available small molecules to treat pre-eclampsia that we are aware of. The Translational Obstetrics Group at Melbourne University has generated strong preclinical evidence suggesting esomeprazole as one of the proton pump inhibitors may have potent actions giving it significant potential as a treatment for pre-eclampsia Proton pump inhibitors have been commonly used in pregnancy to treat gastroesophageal reflux disorders and more serious gastrointestinal complications like Helicobacter pylori-infection, peptic and duodenal ulcers and Zollinger-Ellison syndrome. Esomeprazole counters three key steps in pre-eclampsia pathogenesis, by up-regulating heme oxygenase-1 ( strongly decreasing the release of antiangiogenic factors Soluble Fms Like Tyrosine Kinase -1 and soluble endoglin and quenching endothelial dysfunction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03213639
Study type	Interventional
Source	Assiut University
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	March 15, 2018
Completion date	October 15, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03510286` - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting	`NCT03313024` - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting	`NCT04990141` - Molecular Screening Method for Preeclampsia (PREMOM)
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Not yet recruiting	`NCT05999851` - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy	N/A
Recruiting	`NCT02923206` - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis	N/A
Withdrawn	`NCT05016440` - Lisinopril for Renal Protection in Postpartum Preeclamptic Women	N/A
Completed	`NCT02384226` - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed	`NCT02554604` - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Terminated	`NCT02558023` - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine	Phase 3
Completed	`NCT02854501` - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Not yet recruiting	`NCT02541110` - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler	N/A
Recruiting	`NCT02337049` - Preeclampsia Subtypes and Surrogate Markers of CVD Risk	N/A
Recruiting	`NCT02247297` - Pancreatic Stone Protein (PSP) in Pregnant Women
Completed	`NCT02238704` - Cornell University-Micronutrient Initiative Calcium Supplementation Study	N/A
Withdrawn	`NCT01179542` - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR	N/A
Completed	`NCT01195441` - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound	N/A
Completed	`NCT00456118` - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting	`NCT00117546` - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia	Phase 4
Completed	`NCT00787241` - Platelet Count Trends in Pre-eclamptic Parturients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.