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Trial record 42 of 56 for:    severe preeclampsia AND weeks of gestation

Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

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ClinicalTrials.gov Identifier: NCT03724838
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
Previous studies have shown that expectant management of preeclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. In this study, we evaluate the use of Esomeprazole alone or with Sildenafil Citrate for the treatment of singleton pregnancies complicated by preeclampsia. We hypothesized that the potential increase in uteroplacental and fetoplacental blood flow with the use of Esomeprazole alone or with Sildenafil Citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Esomeprazole with Sildenafil Citrate Drug: Sildenafil Citrate Drug: Placebo to Esomeprazole Drug: Placebo to Sildenafil Citrate Not Applicable

Detailed Description:
The etiology and pathophysiology of preeclampsia have not been clearly established; impaired immunologic adaptation and genetic incompatibility seem to be involved in deficient trophoblastic implantation. Placental hypoxia and endothelial dysfunction may lead to preeclampsia through an exacerbated systemic inflammatory reaction. Increased placental expression and secretion of soluble fms-like tyrosine kinase 1 appear to play a central role in the pathogenesis of preeclampsia. The soluble fms-like tyrosine kinase 1 antagonizes the proangiogenic biologic activity of circulating vascular endothelial growth factor and placental growth factor, leading to a failure of nitric oxide signaling to smooth muscle The investigators will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.
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: Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 1, 2022


Arm Intervention/treatment
Active Comparator: Esomeprazole with Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours
Drug: Esomeprazole with Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day
Other Name: Active Comparator

Drug: Sildenafil Citrate
Patients will take Sildenafil Citrate 40mg every 8 hours
Other Name: active comparator

Active Comparator: Esomeprazole alone plus placebo to Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours
Drug: Esomeprazole with Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day
Other Name: Active Comparator

Drug: Placebo to Sildenafil Citrate
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

Placebo Comparator: placebo to Esomeprazole plus placebo to Sildenafil Citrate
Patients will take placebo identical in shape and consistency with esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours
Drug: Placebo to Esomeprazole
Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day

Drug: Placebo to Sildenafil Citrate
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours




Primary Outcome Measures :
  1. Prolongation of gestation measured from the time of enrollment to the time of delivery. [ Time Frame: 3 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. Side effects [ Time Frame: 4 weeks ]
    any side effects or adverse events related to the intervention, intervention stopped due to side effects

  3. 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



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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 sildenafil citrate
  • Contraindications to the use of esomeprazole or sildenafil citrate
  • The patient is unable or unwilling to give consent
  • An established fetal compromise that necessitates delivery

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): NCT03724838


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, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03724838     History of Changes
Other Study ID Numbers: aswu 193/7/18
First Posted: October 30, 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:
Esomeprazole
Sildenafil Citrate
preterm preeclampsia
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Sildenafil Citrate
Esomeprazole
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors