Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
Study NCT ID:
NCT03105661
Status:
UNKNOWN
Last Update Posted:
2019-02-22
First Post:
2017-04-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007741', 'term': 'Labetalol'}, {'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D020005', 'term': 'Propanols'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to treatment or non treatment group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of preeclampsia in morbidly obese pregnant women', 'timeFrame': '2 years', 'description': 'Rates of preeclampsia in morbidly obese pregnant women'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Preeclampsia']}, 'descriptionModule': {'briefSummary': 'To determine if the use of impedance cardiography can identify appropriate medications for use in treating morbidly obese patients to decrease the risk of preeclampsia.', 'detailedDescription': 'Research Protocol\n\nUse of Impedance Cardiography to decrease the risk of preeclampsia in obese patients\n\nBackground: Obesity is epidemic in the United States and this is leading to an increase in the number of pregnant patients with obesity. Obesity, especially morbid obesity (BMI \\>/= 40), increases the risk of developing preeclampsia when compared to the non-obese population. Impedance Cardiography has never been used to evaluate this patient population to see if they have abnormal cardiac output and/or abnormal peripheral resistance. If identified, low dose medical treatment can be done to normalize these patterns early on to see if this treatment modality decreases the development of preeclampsia and other pregnancy complications.\n\nSpecific Aims: The primary aim of this study is to determine if the use of Impedance Cardiography can help identify the appropriate medicine for use in treating morbidly obese patients that have abnormal testing results, to see if by normalizing impedance cardiography testing parameters results in a decrease in the incidence of preeclampsia in general and other pregnancy complications.\n\nEnrollment: All pregnant patients, 18-51 years old, less than 20 weeks pregnant, with a BMI \\>/= 40 will undergo impedance cardiography and if the results are abnormal, will be provided informed consent to participate. If consent is given, and blood pressure is \\< 140/90,they will be eligible for enrollment.\n\nRandomization: All patients who meet criteria will undergo impedance cardiography. Those with abnormal results will be randomized as the whether they will be treated or not. Randomization will require they blindly pull a paper labelled "yes" or "no" from a container. Those who select "yes" will be randomized to the treatment arm and will be prescribed antihypertensive medications commonly used in obstetrics for hypertension (labetalol, nifedipine, atenolol) Those who select "no" will not receive medication.\n\nStudy Procedure: All pregnant patients that meet study criteria and have abnormal Impedance Cardiography testing will be asked to participate, consented and randomized to the treatment or non treatment arm. The treatment group will receive antihypertensive medications as listed above and undergo monthly cardiography testing after beginning treatment with medication adjustments until normal test results are obtained. The non treatment group will undergo repeat cardiography testing 8 weeks after the first test to compare results. All enrolled patients will be followed with regular prenatal care for their prospective conditions and followed closely for the development of high or low blood pressure and preeclampsia.\n\nAdverse events: Adverse events related to this study are minimal because the test is non invasive and complications for Impedance Cardiology are non existent. In addition, the drugs used to treat hypertension have been used in obstetrics for over 30 years with good results and minimal problems.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients 18-51 years old,\n* Less than 20 weeks gestation with Morbid Obesity (BMI \\>/= 40)\n* Not on antihypertensive medications\n\nExclusion Criteria:\n\n* Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy\n* Patients who have a blood pressure 140/90 or greater'}, 'identificationModule': {'nctId': 'NCT03105661', 'briefTitle': 'Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee Graduate School of Medicine'}, 'officialTitle': 'Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients', 'orgStudyIdInfo': {'id': '4226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'description': 'Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.\n\nLabetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily', 'interventionNames': ['Drug: Labetalol Hydrochloride 200 mg', 'Drug: NIFEdipine 60 mg', 'Drug: Atenolol 25 mg']}, {'type': 'NO_INTERVENTION', 'label': 'Non-treatment Arm', 'description': 'Patients who are randomized to the non-treatment arm will not receive antihypertensive medications.'}], 'interventions': [{'name': 'Labetalol Hydrochloride 200 mg', 'type': 'DRUG', 'otherNames': ['Trandate'], 'description': 'Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography', 'armGroupLabels': ['Treatment Arm']}, {'name': 'NIFEdipine 60 mg', 'type': 'DRUG', 'otherNames': ['Procardia'], 'description': 'Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Atenolol 25 mg', 'type': 'DRUG', 'otherNames': ['Tenormin'], 'description': 'Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Craig V. Towers, MD', 'role': 'CONTACT', 'email': 'ctowers@utmck.edu', 'phone': '865-305-8888'}, {'name': 'Mary Ellen McNeal, BSN, RN', 'role': 'CONTACT', 'email': 'mmcneal@utmck.edu', 'phone': '865-305-8888', 'phoneExt': '3275'}], 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'centralContacts': [{'name': 'Craig V. Towers, MD', 'role': 'CONTACT', 'email': 'ctowers@utmck.edu', 'phone': '865-305-8888'}, {'name': 'Mary Ellen McNeal, BSN, RN', 'role': 'CONTACT', 'email': 'mmcneal@utmck.edu', 'phone': '865-305-8888', 'phoneExt': '3275'}], 'overallOfficials': [{'name': 'Craig V. Towers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee Graduate School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee Graduate School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Mary Ellen McNeal', 'investigatorAffiliation': 'University of Tennessee Graduate School of Medicine'}}}}