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Esomeprazole for the Prevention of Preeclampsia

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ClinicalTrials.gov Identifier: NCT03717740
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Esomeprazole Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The population of interest involves women attending the study hospital for antenatal care and delivery. 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: both participants and researchers will be blinded to the intervention given.
Primary Purpose: Prevention
Official Title: A Randomized Double-Blinded Placebo-Controlled Trial of Esomeprazole for the Prevention of Preeclampsia in Moderate- and High-Risk Women: The ESOPOP Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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,
Drug: 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
Other Name: Experimental

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,
Drug: Placebo
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 Name: Placebo Comparator




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. The number of cases of preterm birth [ Time Frame: 6 months ]
    The number of cases delivered before complet 37 weeks gestation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The population of interest involves women attending the study hospital for antenatal care and delivery
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717740


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, m    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03717740     History of Changes
Other Study ID Numbers: aswu/291/9/18
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by hany farouk, Aswan University Hospital:
preeclampsia
esomeprazole
Soluble Fms Like Tyrosine Kinase -1
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action