Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination metformin and esomeprazole | Experimental | Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery. |
|
| expectant management | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 20mg | Drug | Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean plasma difference in sFlt-1 from randomization to day 7 | from randomization to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plasma difference in vascular endothelial growth factor (VEGF) | from randomization to day 7 | |
| Mean plasma difference in placental growth factor (PlGF) levels | from randomization to day 7 | |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwan Ma'ayeh, MD | Contact | 302-319-5680 | maayehmarwan@gmail.com | |
| Kendall M Bielak, MD | Contact | 302-320-4414 | kendall.bielak@christianaacare.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Hoffman, MD, MPH | ChristianaCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Systems | Newark | Delaware | 19713 | United States |
Not provided
Data are available for 5 years at a third party website
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean plasma difference in soluble endoglin (sEng) |
| from randomization to day 7 |
| Maternal death | At time of delivery |
| Mean highest blood pressure during expectant management mmHg | At time of delivery |
| Number of anti-hypertensive medications at delivery | 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 | at time of delivery |
| Gestational age at delivery | at time of delivery |
| Neonatal intensive care unit (nicu) admission | at time of delivery |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |