Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2021
• Main ID: NCT03213639
• Date of registration: 08/07/2017
• Prospective Registration: Yes
• Primary sponsor: Assiut University
• Public title: Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)
• Scientific title: Use of Esomeprazole in Treatment of Early Onset Preeclampsia:a Double Blind Randomized, Placebo-controlled Trial
• Date of first enrolment: March 15, 2018
• Target sample size: 205
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03213639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Ahmed Abbas, MD
• Affiliation: Assiut University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Preeclampsia

Intervention(s)

Drug: Placebo Oral Tablet

Drug: Esomeprazole 40 mg Oral Tablet

Primary Outcome(s)

Number of women who develop HELLP syndrome [Time Frame: 1 month]

The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy [Time Frame: 2 weeks]

Secondary Outcome(s)

Prolongation of gestation measured from the time of enrollment to the time of delivery [Time Frame: 2 weeks]

The side effects of the drugs [Time Frame: 2 weeks]

Secondary ID(s)

ESOPE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors