Preeclampsia SeverePhase 1NCT05232994
Metformin and Esomeprazole For Preterm Pre-eclampsia
A Phase 1 study testing Esomeprazole 20mg in people with Preeclampsia Severe and Preeclampsia Second Trimester, run by Christiana Care Health Services at 1 site in United States.
Trial summary
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Preeclampsia Severe, Preeclampsia Second Trimester, Preterm Birth Complication
- What is being tested?
- Esomeprazole 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Phase 1
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies
- Women 18 years or older
- Women diagnosed with preeclampsia
- Women with pre-eclampsia superimposed on chronic hypertension
- Candidates for expectant management and had no clinical indication for immediate delivery
Who cannot join
- Delivery within 48hr is highly likely
- Maternal or fetal compromise that necessitated immediate delivery
- Diabetes or gestational diabetes currently on metformin therapy
- Contraindications to metformin, esomeprazole
- Baseline creatinine >124 μmol/L
- Hypersensitivity to metformin or esomeprazole
- Metabolic acidosis
- Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Systems
Newark, Delaware, 19713
Marwan Ma'ayeh, MD, 302-320-5680, maayehmarwan@gmail.com
Matthew Hoffman, MD, MPH
About this study
Official title: Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.
- Being tested
- Esomeprazole 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 20mgDrug
Also called Metformin
Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.
| Study group | Role | What they receive |
|---|---|---|
| combination metformin and esomeprazole | Experimental | Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery. Receives: Drug: Esomeprazole 20mg |
| expectant management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean plasma difference in sFlt-1 from randomization to day 7
Measured: from randomization to day 7
Secondary outcomes (9)
Mean plasma difference in vascular endothelial growth factor (VEGF)
Measured: from randomization to day 7
Mean plasma difference in placental growth factor (PlGF) levels
Measured: from randomization to day 7
Mean plasma difference in soluble endoglin (sEng)
Measured: from randomization to day 7
Maternal death
Measured: At time of delivery
Mean highest blood pressure during expectant management mmHg
Measured: At time of delivery
Number of anti-hypertensive medications at delivery
Measured: at time of delivery
Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs
Measured: at time of delivery
Gestational age at delivery
Measured: at time of delivery
Neonatal intensive care unit (nicu) admission
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia SevereStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Hoffman, MD, MPH, Principal investigator, ChristianaCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232994
- Sponsor's protocol ID
- DDD# 605095
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05232994
- Acronym / sponsor ID
- DDD# 605095
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Feb 2022 (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.
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination metformin and esomeprazole | Experimental | Drug: Esomeprazole 20mgCombination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery. |
| expectant management | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies
- Women 18 years or older
- Women diagnosed with preeclampsia
- Women with pre-eclampsia superimposed on chronic hypertension
- Candidates for expectant management and had no clinical indication for immediate delivery
Key exclusion criteria (8 listed)
- Delivery within 48hr is highly likely
- Maternal or fetal compromise that necessitated immediate delivery
- Diabetes or gestational diabetes currently on metformin therapy
- Contraindications to metformin, esomeprazole
- Baseline creatinine >124 μmol/L
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 20mgAlso: MetforminCombination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery. | Drug | combination metformin and esomeprazole |
Primary outcome
mean plasma difference in sFlt-1 from randomization to day 7
Time frame: from randomization to day 7
9 secondary outcomes
Mean plasma difference in vascular endothelial growth factor (VEGF)
Time frame: from randomization to day 7
Mean plasma difference in placental growth factor (PlGF) levels
Time frame: from randomization to day 7
Mean plasma difference in soluble endoglin (sEng)
Time frame: from randomization to day 7
Maternal death
Time frame: At time of delivery
Mean highest blood pressure during expectant management mmHg
Time frame: At time of delivery
Number of anti-hypertensive medications at delivery
Time frame: at time of delivery
Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs
Time frame: at time of delivery
Gestational age at delivery
Time frame: at time of delivery
Neonatal intensive care unit (nicu) admission
Time frame: at time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
Matthew Hoffman, MD, MPH principal investigator
ChristianaCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esomeprazole 20mg in people with Preeclampsia Severe and Preeclampsia Second Trimester, run by Christiana Care Health Services at 1 site in United States.
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 5 inclusion and 8 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 Feb 2023. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marwan Ma'ayeh, MD (302-319-5680, maayehmarwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean plasma difference in sFlt-1 from randomization to day 7 (time frame: from randomization to day 7). 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 Feb 2023.