Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03570632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gestational weight gain', 'timeFrame': 'At time of prenatal visits, throughout pregnancy from enrollment to delivery'}, {'measure': 'Umbilical cord c-peptide', 'timeFrame': 'Delivery/End of pregnancy'}, {'measure': 'Umbilical cord glucose', 'timeFrame': 'Delivery/End of pregnancy'}, {'measure': 'Neonatal body composition', 'timeFrame': 'Delivery/End of pregnancy'}], 'primaryOutcomes': [{'measure': 'Rate of hypertensive disorders of pregnancy', 'timeFrame': 'Delivery/End of pregnancy'}], 'secondaryOutcomes': [{'measure': 'Home glucose levels throughout pregnancy', 'timeFrame': 'Weekly, throughout pregnancy from enrollment to delivery'}, {'measure': 'Birthweight', 'timeFrame': 'Delivery/End of pregnancy'}, {'measure': 'Neonatal morbidity', 'timeFrame': 'Delivery/End of pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Pregnancy in Diabetes']}, 'descriptionModule': {'briefSummary': "Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only pregnant women are eligible to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women 18-50 years\n* 12 0/7 and 19 6/7 weeks of gestation\n* Diagnosed with type 1 DM prior to pregnancy.\n\nExclusion Criteria:\n\n* Known allergy or adverse reaction to metformin\n* Multiple gestation\n* Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy\n* Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \\> 1.1 mg/dL), proteinuria (P:C \\>0.3 or 24-hour urine protein \\> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia)."}, 'identificationModule': {'nctId': 'NCT03570632', 'briefTitle': 'Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'STUDY19060327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Maisa N Feghali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisa N. Feghali, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Maisa N. Feghali, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}