Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)

• Status: Completed
• Trial end date: 2020-10-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• Gestational age between 28 + 0 weeks and 31 + 6 weeks

• Estimated fetal weight by ultrasound between 500 gm and 1800 gm (if gestation is not certain).

• Singleton pregnancy.

• The patient will be managed with expectant management.

Exclusion Criteria:

• Patient is unable or unwilling to give consent

• Established fetal compromise that necessitates delivery.

• The presence of any of the following at presentation:

• Eclampsia.

• Severe hypertension.

• Cerebrovascular event as an ischaemic or haemorrhagic stroke.

• Renal impairment.

• Signs of left ventricular failure which include pulmonary oedema.

• Disseminated intravascular coagulation (DIC)

• Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)

• Fetal distress on cardiotocography

• Contra-indications for expectant management of pre-eclampsia

• Current use of a proton pump inhibitor

• Contraindications to the use of a proton pump inhibitor

• Previous hypersensitivity reaction to a proton pump inhibitor