Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT05673135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000959', 'term': 'Antihypertensive Agents'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D015992', 'term': 'Body Mass Index'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D001699', 'term': 'Biometry'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of adverse maternal outcome related to hypertension in both groups', 'timeFrame': '3 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': 'Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks\' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged from 20-35 years.\n2. Pregnant women from 28-30 weeks.\n3. Pregnant women with a singleton pregnancy.\n4. Women with chronic or gestational hypertension.\n5. Women with normal baseline investigations (uncomplicated hypertension).\n6. Obese women and non-obese women.\n\nExclusion Criteria:\n\n1. Women with preeclampsia/eclampsia.\n2. Women need urgent termination of pregnancy.\n3. Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.\n4. Women with confirmed fetal malformation.\n5. Women who will refuse to participate.'}, 'identificationModule': {'nctId': 'NCT05673135', 'briefTitle': 'The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women', 'orgStudyIdInfo': {'id': 'HT-pre'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-obese hypertensive pregnant women', 'interventionNames': ['Drug: Anti-Hypertensive', 'Radiation: Ultrasound', 'Radiation: Doppler ultrasound', 'Diagnostic Test: complete blood count', 'Diagnostic Test: Body mass index']}, {'type': 'OTHER', 'label': 'Obese hypertensive pregnant women', 'interventionNames': ['Drug: Anti-Hypertensive', 'Radiation: Ultrasound', 'Radiation: Doppler ultrasound', 'Diagnostic Test: complete blood count', 'Diagnostic Test: Body mass index']}], 'interventions': [{'name': 'Anti-Hypertensive', 'type': 'DRUG', 'description': 'For control of the blood pressure', 'armGroupLabels': ['Non-obese hypertensive pregnant women', 'Obese hypertensive pregnant women']}, {'name': 'Ultrasound', 'type': 'RADIATION', 'description': 'For assessment of gestational age and fetal weight', 'armGroupLabels': ['Non-obese hypertensive pregnant women', 'Obese hypertensive pregnant women']}, {'name': 'Doppler ultrasound', 'type': 'RADIATION', 'description': 'Umbilical artery Doppler assessment', 'armGroupLabels': ['Non-obese hypertensive pregnant women', 'Obese hypertensive pregnant women']}, {'name': 'complete blood count', 'type': 'DIAGNOSTIC_TEST', 'description': 'For assessment of platelet count', 'armGroupLabels': ['Non-obese hypertensive pregnant women', 'Obese hypertensive pregnant women']}, {'name': 'Body mass index', 'type': 'DIAGNOSTIC_TEST', 'description': 'for assessment of maternal weight during pregnancy', 'armGroupLabels': ['Non-obese hypertensive pregnant women', 'Obese hypertensive pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Women Health Hospital - Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohammed Khairy Ali', 'investigatorAffiliation': 'Assiut University'}}}}