A Phase 1 interventional study of Esomeprazole 20mg in Preeclampsia Severe, Preeclampsia Second Trimester and Preterm Birth Complication, sponsored by Christiana Care Health Services. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Christiana Care Health Services · Phase 1, Interventional, and Prevention
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 38 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.
Drug: Esomeprazole 20mg
Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.
Also known as: Metformin
mean plasma difference in sFlt-1 from randomization to day 7
Time frame: from randomization to day 7
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data are available for 5 years at a third party website
No publications or documents are linked to this record.
Start is estimated for Mar 2023; primary completion for Dec 2024, 21 months later.
Of 20 phase 1 interventional studies under Pre-Eclampsia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 34. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esomeprazole
Christiana Care Health Services