Pre-EclampsiaNCT03717701
Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia
A study testing metformin and esomeprazole in people with Pre-Eclampsia, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- metformin and esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Jan 2021
- 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 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:
Show all 13Show fewer
- 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)
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: Combining Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia: A Double-Blind Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Pre-Eclampsia
- Being tested
- metformin, esomeprazole, Placebo
- Keywords
- preeclampsia, esomeprazole, metformin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
Also called Experimental
Patients will take metformin single dose of 1000 mg orally once a day
esomeprazoleDrug
Also called Experimental
Patients will take esomeprazole single dose of 40 mg orally once a day
PlaceboDrug
Patients will take inert tablets similar in appearance, color, and consistency
| Study group | Role | What they receive |
|---|---|---|
| metformin and esomeprazole | Experimental | 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 Receives: Drug: metformin; Drug: esomeprazole |
| Placebo | Placebo comparator | Patients will take inert tablets similar in appearance, color, and consistency Receives: Drug: Placebo |
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: 4 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
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
Side effects
any side effects or adverse events related to the intervention, intervention stopped due to side effects
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 posted24 Oct 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- This is a randomized double-blinded placebo-controlled intervention trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717701
- Sponsor's protocol ID
- aswu/273/9l18
- Status last verified
- Jan 2019
- First submitted
- 22 Oct 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- 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
- Combining Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia: A Double-Blind Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03717701
- Acronym / sponsor ID
- aswu/273/9l18
- Conditions
- Pre-Eclampsia
- Keywords
- preeclampsia, esomeprazole, metformin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 24 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized double-blinded placebo-controlled intervention trial
| Arm | Type | Receives |
|---|---|---|
| metformin and esomeprazole | Experimental | Drug: metformin, Drug: esomeprazolePatients will take esomeprazole single dose of 40 mg orally once a day plus single dose of metformin 1000mg orally single dose once a day |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take inert tablets similar in appearance, color, and consistency |
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 (13 listed)
- 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
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 |
|---|---|---|
| metforminAlso: ExperimentalPatients will take metformin single dose of 1000 mg orally once a day | Drug | metformin and esomeprazole |
| esomeprazoleAlso: ExperimentalPatients will take esomeprazole single dose of 40 mg orally once a day | Drug | metformin and esomeprazole |
| PlaceboPatients will take inert tablets similar in appearance, color, and consistency | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Severe morbidity
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
Side effects
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
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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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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 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 metformin and esomeprazole in people with Pre-Eclampsia, 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 13 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: 4 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.