PreeclampsiaNCT03724838
Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia
A study testing Esomeprazole with Sildenafil Citrate and Sildenafil Citrate in people with Preeclampsia, run by Aswan University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Esomeprazole with Sildenafil Citrate and Sildenafil Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, m, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Esomeprazole with Sildenafil Citrate, Sildenafil Citrate, Placebo to Esomeprazole, Placebo to Sildenafil Citrate
- Keywords
- Esomeprazole, Sildenafil Citrate, preterm preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole with Sildenafil CitrateDrug
Also called Active Comparator
Patients will take esomeprazole single dose of 40 mg orally once a day
Sildenafil CitrateDrug
Also called active comparator
Patients will take Sildenafil Citrate 40mg every 8 hours
Placebo to EsomeprazoleDrug
Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day
Placebo to Sildenafil CitrateDrug
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole with Sildenafil Citrate | Active comparator | Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours Receives: Drug: Esomeprazole with Sildenafil Citrate; Drug: Sildenafil Citrate |
| Esomeprazole alone plus placebo to Sildenafil Citrate | Active comparator | 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 Receives: Drug: Esomeprazole with Sildenafil Citrate; Drug: Placebo to Sildenafil Citrate |
| placebo to Esomeprazole plus placebo to Sildenafil Citrate | Placebo comparator | 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 Receives: Drug: Placebo to Esomeprazole; Drug: Placebo to Sildenafil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of gestation measured from the time of enrollment to the time of delivery.
Prolongation of gestation measured from the time of enrollment to the time of delivery
Measured: 3 weeks
Secondary outcomes (3)
Severe morbidity
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
Measured: 4 weeks
Side effects
any side effects or adverse events related to the intervention, intervention stopped due to side effects
Measured: 4 weeks
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724838
- Sponsor's protocol ID
- aswu 193/7/18
- Status last verified
- Jan 2019
- First submitted
- 29 Oct 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03724838
- Acronym / sponsor ID
- aswu 193/7/18
- Conditions
- Preeclampsia
- Keywords
- Esomeprazole, Sildenafil Citrate, preterm preeclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole with Sildenafil Citrate | Active comparator | Drug: Esomeprazole with Sildenafil Citrate, Drug: Sildenafil CitratePatients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours |
| Esomeprazole alone plus placebo to Sildenafil Citrate | Active comparator | Drug: Esomeprazole with Sildenafil Citrate, Drug: Placebo to Sildenafil CitratePatients 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 |
| placebo to Esomeprazole plus placebo to Sildenafil Citrate | Placebo comparator | Drug: Placebo to Esomeprazole, Drug: Placebo to Sildenafil CitratePatients 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole with Sildenafil CitrateAlso: Active ComparatorPatients will take esomeprazole single dose of 40 mg orally once a day | Drug | Esomeprazole alone plus placebo to Sildenafil Citrate, Esomeprazole with Sildenafil Citrate |
| Sildenafil CitrateAlso: active comparatorPatients will take Sildenafil Citrate 40mg every 8 hours | Drug | Esomeprazole with Sildenafil Citrate |
| Placebo to EsomeprazolePatients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day | Drug | placebo to Esomeprazole plus placebo to Sildenafil Citrate |
| Placebo to Sildenafil CitratePatients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours | Drug | Esomeprazole alone plus placebo to Sildenafil Citrate, placebo to Esomeprazole plus placebo to Sildenafil Citrate |
Primary outcome
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
3 secondary outcomes
Severe morbidity
Time frame: 4 weeks
Side effects
Time frame: 4 weeks
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole with Sildenafil Citrate and Sildenafil Citrate in people with Preeclampsia, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f sallam (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolongation of gestation measured from the time of enrollment to the time of delivery. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.