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Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

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ClinicalTrials.gov Identifier: NCT03717701
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 is globally responsible for tens of thousands of maternal and neonatal deaths each year. Currently, there are no medical therapies to halt disease progression and expectant management and delivery remain the mainstay of treatment. An important step in the pathogenesis of preeclampsia is a poor placental invasion and the subsequent release of the anti-angiogenic factors soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng)into the maternal circulation. Given metformin and esomeprazole successfully mitigate key pathogenic features of preeclampsia, the investigator will study whether combining low-doses of metformin and esomeprazole may be additive or synergistic (or neither) in reducing sFlt-1 and sEng secretion, and mitigating endothelial dysfunction, compared to placebo.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: metformin Drug: esomeprazole Drug: Placebo Not Applicable

Detailed Description:
This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the International Society for the Study of Hypertension in Pregnancy (ISSHP). The population of interest involves pregnant women diagnosed with pre-eclampsia at a gestational age between 28 and 32 weeks at Aswan university hospital will be invited to participate. To be enrolled, the treating team needs to have determined after their initial assessment that delivery is unlikely to be required within 48 h. A starting point of 28 weeks has been chosen as this would be the earliest gestation that Aswan university hospital to be viable and are suitable to be offered expectant management The intervention involves randomization to oral esomeprazole tablets40 mg plus metformin tablets 1000 mg or identical placebo tablets from recruitment until delivery. Randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized double-blinded placebo-controlled intervention trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: both participants and researchers will be blinded to the intervention given
Primary Purpose: Treatment
Official Title: Combining Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia: A Double-Blind Randomized, Placebo-controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: metformin and esomeprazole
Patients will take esomeprazole single dose of 40 mg orally once a day plus single dose of metformin 1000mg orally single dose once a day
Drug: metformin
Patients will take metformin single dose of 1000 mg orally once a day
Other Name: Experimental

Drug: esomeprazole
Patients will take esomeprazole single dose of 40 mg orally once a day
Other Name: Experimental

Placebo Comparator: Placebo
Patients will take inert tablets similar in appearance, color, and consistency
Drug: Placebo
Patients will take inert tablets similar in appearance, color, and consistency




Primary Outcome Measures :
  1. Prolongation of gestation measured from the time of enrollment to the time of delivery. [ Time Frame: 4 weeks ]
    Prolongation of gestation measured from the time of enrollment to the time of delivery.


Secondary Outcome Measures :
  1. Severe morbidity [ Time Frame: 4 weeks ]
    Severe morbidity including eclampsia, liver or renal failure, hemolysis, elevated liver enzymes and low platelets syndrome (HELLP), disseminated intravascular coagulation (DIC), stroke, and pulmonary edema

  2. The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy [ Time Frame: 4 weeks ]
    The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy

  3. Side effects [ Time Frame: 4 weeks ]
    any side effects or adverse events related to the intervention, intervention stopped due to side effects



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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:   pregnant women with early-onset preeclampsia
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
  • The patient will be managed with an expectant management
  • Give written informed consent

Exclusion Criteria:

  • Multiple pregnancies.
  • Previous hypersensitivity reaction esomeprazole or metformin
  • Contraindications to the use of esomeprazole or metformin
  • The patient is unable or unwilling to give consent
  • An established fetal compromise that necessitates delivery
  • The presence of any of the following at presentation:

    • Eclampsia.
    • Severe hypertension.
    • A cerebrovascular event as an ischemic or hemorrhagic stroke.
    • Renal impairment.
    • Signs of left ventricular failure which include pulmonary edema.
    • Disseminated intravascular coagulation (DIC)
    • Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)

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): NCT03717701


Contacts
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Contact: hany f sallam 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 Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03717701     History of Changes
Other Study ID Numbers: aswu/273/9l18
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
metformin
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Metformin
Esomeprazole
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action