Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT05232994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-10
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Esomeprazole For Preterm Pre-eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean plasma difference in sFlt-1 from randomization to day 7', 'timeFrame': 'from randomization to day 7'}], 'secondaryOutcomes': [{'measure': 'Mean plasma difference in vascular endothelial growth factor (VEGF)', 'timeFrame': 'from randomization to day 7'}, {'measure': 'Mean plasma difference in placental growth factor (PlGF) levels', 'timeFrame': 'from randomization to day 7'}, {'measure': 'Mean plasma difference in soluble endoglin (sEng)', 'timeFrame': 'from randomization to day 7'}, {'measure': 'Maternal death', 'timeFrame': 'At time of delivery'}, {'measure': 'Mean highest blood pressure during expectant management mmHg', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of anti-hypertensive medications at delivery', 'timeFrame': 'at time of delivery'}, {'measure': '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', 'timeFrame': 'at time of delivery'}, {'measure': 'Gestational age at delivery', 'timeFrame': 'at time of delivery'}, {'measure': 'Neonatal intensive care unit (nicu) admission', 'timeFrame': 'at time of delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia Severe', 'Preeclampsia Second Trimester', 'Preterm Birth Complication']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies\n\n* Women 18 years or older\n* Women diagnosed with preeclampsia\n* Women with pre-eclampsia superimposed on chronic hypertension\n* Candidates for expectant management and had no clinical indication for immediate delivery\n\nExclusion Criteria:\n\n* Delivery within 48hr is highly likely\n* Maternal or fetal compromise that necessitated immediate delivery\n* Diabetes or gestational diabetes currently on metformin therapy\n* Contraindications to metformin, esomeprazole\n* Baseline creatinine \\>124 μmol/L\n* Hypersensitivity to metformin or esomeprazole\n* Metabolic acidosis\n* Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations'}, 'identificationModule': {'nctId': 'NCT05232994', 'briefTitle': 'Metformin and Esomeprazole For Preterm Pre-eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DDD# 605095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combination metformin and esomeprazole', 'description': 'Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.', 'interventionNames': ['Drug: Esomeprazole 20mg']}, {'type': 'NO_INTERVENTION', 'label': 'expectant management'}], 'interventions': [{'name': 'Esomeprazole 20mg', 'type': 'DRUG', 'otherNames': ['Metformin'], 'description': 'Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.', 'armGroupLabels': ['combination metformin and esomeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'contacts': [{'name': "Marwan Ma'ayeh, MD", 'role': 'CONTACT', 'email': 'maayehmarwan@gmail.com', 'phone': '302-320-5680'}, {'name': 'Matthew Hoffman, MD, MPH', 'role': 'CONTACT'}], 'facility': 'Christiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'centralContacts': [{'name': "Marwan Ma'ayeh, MD", 'role': 'CONTACT', 'email': 'maayehmarwan@gmail.com', 'phone': '302-319-5680'}, {'name': 'Kendall M Bielak, MD', 'role': 'CONTACT', 'email': 'kendall.bielak@christianaacare.org', 'phone': '302-320-4414'}], 'overallOfficials': [{'name': 'Matthew Hoffman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ChristianaCare'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data are available for 5 years at a third party website', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}