- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717740
Esomeprazole for the Prevention of Preeclampsia
January 8, 2019 updated by: hany farouk, Aswan University Hospital
A Randomized Double-Blinded Placebo-Controlled Trial of Esomeprazole for the Prevention of Preeclampsia in Moderate- and High-Risk Women: The ESOPOP Trial
Preeclampsia, one of the hypertensive disorders of pregnancy, remains a leading cause of maternal death worldwide, with the majority of deaths occurring in developing countries.
Preeclampsia is a multi-organ syndrome of pregnancy that manifests after 20 weeks' gestation with new-onset hypertension alongside maternal end-organ dysfunction and/or fetal growth restriction.
Importantly, preeclampsia poses serious health risks for the baby, implicated in 12% of cases of fetal growth restriction, and is a known antecedent in up to 19% of preterm births.
There is currently no effective treatment for preeclampsia except delivery of the baby, and as such, it remains a significant burden of disease for both mothers and their babies worldwide.
Screening for women at risk of preeclampsia is an important part of antenatal care.
Once women are identified as high risk, they can be targeted for more intensive antenatal surveillance and prophylactic interventions.
Most current strategies for risk assessment are based on obstetric and medical history and clinical examination.
However, there is surprisingly little reliable evidence on the actual risk associated with individual factors and how they might interact.
Risk factors with a particularly high association with preeclampsia (more than one in ten risks) include maternal diabetes, chronic hypertension, and renal disease.
Thrombophilia and autoimmune disease have a strong association with severe early-onset preeclampsia.
Obstetric factors associated with high risk are multiple pregnancies, history of preeclampsia in a previous pregnancy especially if severe or early onset, and a current hydropic pregnancy.
Other factors linked with preeclampsia but associated with a somewhat lower risk include first pregnancies, age less than 20 or more than 35 years, a family history of preeclampsia, and obesity.
Proton pump inhibitors such as esomeprazole have long-term safety data about the treatment of gastric reflux in pregnancy.
In vitro studies show proton pump inhibitors decrease soluble fems like tyrosine kinase -1 (sFlt-1) and soluble endoglin and improve markers of endothelial dysfunction .
while esomeprazole reduces blood pressure in a preeclampsia transgenic mouse model that overexpresses sFlt-1.
Study Overview
Detailed Description
This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the National Institute of Clinical Excellence (NICE).
The population of interest involves women attending the study hospital for antenatal care and delivery with a risk for developing preeclampsia.
The intervention involves randomization to oral esomeprazole tablets40 mg or identical placebo tablet from recruitment until delivery.
Randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given.
Calculation of the sample size considers that the incidence of preeclampsia is 10% in the population of interest.
To detect a 50% reduction in incidence (with 80% power, two-sided p < 0.05), 450 women are required in each group with a 1:1 ratio.
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aswan, Egypt, 81528
- Recruiting
- Aswan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Pregnant women presenting prior to 17+0 weeks' gestation.
- Moderate to high risk of preeclampsia. One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI > 25, and maternal age <20 or >35.
- Give written informed consent.
Exclusion Criteria:
- Multiple pregnancies.
- Current or previous esomeprazole ingestion within the last 6 weeks.
- Previous hypersensitivity reaction esomeprazole
- Contraindications to the use of a proton pump inhibitor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Esomeprazole
Patients will take esomeprazole single dose of 40 mg orally once a day from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy,
|
Patients will take esomeprazole single dose of 40 mg orally once a day from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Patients will take Placebo Oral Tablet once a daily oral tablet from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy,
|
Patients will take an inert tablet similar in appearance, color, and consistency from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With early onset Preeclampsia
Time Frame: 6 months
|
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300 mg in 24 hrs) before 34 weeks gestation
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of cases of Fetal Growth Restriction
Time Frame: 6 months
|
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
|
6 months
|
Prevention of preeclampsia between 37 and 41
Time Frame: 6 months
|
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
|
6 months
|
The number of cases of preterm birth
Time Frame: 6 months
|
The number of cases delivered before complet 37 weeks gestation
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2018
Primary Completion (ANTICIPATED)
November 30, 2021
Study Completion (ANTICIPATED)
January 1, 2022
Study Registration Dates
First Submitted
October 22, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (ACTUAL)
October 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aswu/291/9/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pre-Eclampsia
-
Assiut UniversityNot yet recruitingPre-eclampsia Aggravated | Pre-Eclampsia; Complicating Pregnancy
-
Dow University of Health SciencesCompletedPre-eclampsia | Hypertension, Pregnancy Induced | Hydralazine Adverse Reaction | Pre-eclampsia Superimposed Pre-existing HypertensionPakistan
-
University of WashingtonUniversity of Cape TownCompletedSevere Pre-eclampsia | Mild Pre-eclampsiaSouth Africa, United States
-
William Marsh Rice UniversityUniversity of MalawiCompleted
-
Duke UniversityTerminated
-
William Marsh Rice UniversityCompletedPre EclampsiaUnited States
-
Oxford University Hospitals NHS TrustUniversity of CambridgeTerminated
-
Novartis PharmaceuticalsTerminatedPre-eclampsiaItaly, United States
-
Ain Shams UniversityCompleted
-
Nantes University HospitalCompleted
Clinical Trials on Esomeprazole
-
TakedaCompletedHealthy ParticipantsUnited States
-
Chinese University of Hong KongCompletedBleeding | Peptic UlcerChina
-
National Taiwan University HospitalMinistry of Science and Technology, Taipei, TaiwanCompleted
-
AstraZenecaCompletedRefractory Reflux EsophagitisJapan
-
Bio-innova Co., LtdNot yet recruiting
-
Onconic Therapeutics Inc.Completed
-
Bio-innova Co., LtdNot yet recruiting
-
AstraZenecaCompletedGastroesophageal Reflux Disease (GERD)United States, France, Poland, Germany
-
Chinese University of Hong KongTerminatedGastrointestinal HemorrhageChina
-
Chong Kun Dang PharmaceuticalCompleted