Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 9:54 AM
Study NCT ID:
NCT05867459
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-17', 'releaseDate': '2024-07-10'}], 'estimatedResultsFirstSubmitDate': '2024-07-10'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D016482', 'term': 'Urinalysis'}], 'ancestors': [{'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1) the pregnancy outcomes of patients with CKD (2) additional risk factors for adverse pregnancy outcomes in patients with CKD', 'timeFrame': 'From day of enrollment of pt in study to one week after delivary', 'description': 'Medical and clinial data will collect And retrospectively analyze. The data well collected by multiple visit to pt or telephon calling for follow up data will ensured by report of about pt from obstetric and nicu doctor Evaluation of pregnancy outcomes :Adverse pregnancy outcomes included maternal death, severe preeclampsia ,eclampsia The diagnostic criteria for severe preeclampsia were based on the 2013 Hypertension in Pregnancy Guidelines of the American College of Obstetricians and Gynecologists .\n\nduration of hospital stay and type of care need, mode of delivery ,need of blood transfusion , gestational age during delivary for detet preterm birth and its type, birth weigh for detect low birth Wt and its degree ,NICU admission,IUGR as fetus is 10 centile according gastational age, still birth, ,abortion , and neonatal death, any documented congenital anomalies of fetus.\n\nAnd questionaire of pt for risk factor as DM,HTN,maternal age,drug use during delivary, stage of CKD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CKD PREGNANT WOMEN']}, 'referencesModule': {'references': [{'pmid': '26988973', 'type': 'BACKGROUND', 'citation': 'Cabiddu G, Castellino S, Gernone G, Santoro D, Moroni G, Giannattasio M, Gregorini G, Giacchino F, Attini R, Loi V, Limardo M, Gammaro L, Todros T, Piccoli GB. A best practice position statement on pregnancy in chronic kidney disease: the Italian Study Group on Kidney and Pregnancy. J Nephrol. 2016 Jun;29(3):277-303. doi: 10.1007/s40620-016-0285-6. Epub 2016 Mar 17.'}, {'pmid': '16908915', 'type': 'BACKGROUND', 'citation': 'Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.'}, {'pmid': '11904577', 'type': 'BACKGROUND', 'citation': 'National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.'}, {'pmid': '27350132', 'type': 'RESULT', 'citation': 'Hall M. Pregnancy in Women With CKD: A Success Story. Am J Kidney Dis. 2016 Oct;68(4):633-639. doi: 10.1053/j.ajkd.2016.04.022. Epub 2016 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the work:\n\nIn this study, we aimed:\n\nIs to investigate the following issues: (1) the pregnancy outcomes of patients with CKD (2) additional risk factors for adverse pregnancy outcomes in patients with CKD in the area of sohag governorate.', 'detailedDescription': 'prospective observational study including group of pregnant CKD women The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD .\n\nThe data will be collected by multiple visit and survey of patient in hemodialysis units in sohag governorate and renal outpatient clinic and obstetric department and internal medicine department in sohag university hospital\n\nDuration of study:\n\nnine month after approval of protocol by medical research committee of sohag faculty of medicine\n\nData collection procedure:\n\nThe following clinical data will be collected:\n\nClinical assessment:\n\nage, kidney disease history, history of DM or HTN ,history of pregnancy during study, therapy in early pregnancy (including antihypertensive drugs and immunosuppressive agents), , baseline blood pressure, body weight, body height, and . Mean arterial pressure (MAP) was calculated as (systolic pressure+2×diastolic pressure)/3. Body mass index (BMI) was calculated based on height and body weight. According to age and Scr level, the estimated glomerular filtration rate (eGFR) was calculated by CKD-EPI Creatinine Equation (2021)\n\nEvaluation of pregnancy outcomes :Adverse pregnancy outcomes included maternal death, severe preeclampsia ,eclampsia ,duration of hospital stay and type of care need, mode of delivery ,need of blood transfusion , gestational age during delivary for detet preterm birth\\> 37W early preterm from 28 to 34W or late preterm from 34 to37W or extremely preterm \\> 28W, birth weigh for low birthweight\\> 2500 g ,very low birth weight \\>1500g , extremely low birth weight\\>1000g,NICU admission,IUGR, still birth ,abortion, and neonatal death.\n\nLaboratory assessment:\n\n1. serum creatinine\n2. urine analysis 3-24h protein in urine or albumin create ratio\n\n4-serum electrolyte s.Na s.K ionezed Ca 5-pathological result of renal biopsy if done 6-abdominal ultrasound with full comment on kidney'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient in hemodialysis units in sohag governorate and renal outpatient clinic and obstetric department and internal medicine department in sohag university hospital has the crietria of CKD pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant patients with CKD regardless the cause of CKD in any stage of CKD on dialysis or not.\n\nExclusion Criteria:\n\n* Any patient not defined CKD or serum creatinineless than1,2 befor 13W of pregnancy Grand multipara patient with history of multiple abortion or still birth not related to CKD affection period'}, 'identificationModule': {'nctId': 'NCT05867459', 'briefTitle': 'Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-06MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD PREGNANT PATIENT', 'description': 'The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD', 'interventionNames': ['Diagnostic Test: Serum creatinine', 'Diagnostic Test: Alb /creat ratio or 24h urine protein', 'Diagnostic Test: Serum electrolyte', 'Diagnostic Test: Urine analysis', 'Diagnostic Test: Abdominal ultrasound', 'Diagnostic Test: Renal biobsy', 'Other: Clinical assesment']}], 'interventions': [{'name': 'Serum creatinine', 'type': 'DIAGNOSTIC_TEST', 'description': 'The test wil be measured for all pt in study to detect of their grade of CKD', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Alb /creat ratio or 24h urine protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'Test will be measured to detect type and sevirity of proteinuria', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Serum electrolyte', 'type': 'DIAGNOSTIC_TEST', 'description': 'The test will be measured in all pt to detect renal tubular state', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Urine analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'It is mirror of kidney', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Abdominal ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'To detect the anatomy and any structural abnormality in kidneys', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Renal biobsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Is done but not for all pt but for pt that can do it and agree for it .the test is used for detection of type of CKD or type of glomerionephritis', 'armGroupLabels': ['CKD PREGNANT PATIENT']}, {'name': 'Clinical assesment', 'type': 'OTHER', 'description': 'Clinical assessment:\n\nage, kidney disease history, history of DM or HTN ,history of pregnancy during study, therapy in early pregnancy , body weight, body height, and . Mean arterial pressure (MAP) . Body mass index (BMI). According to age and Scr level, the estimated glomerular filtration rate (eGFR) was calculated by CKD-EPI Creatinine Equation (2021)\n\nEvaluation of pregnancy outcomes :Adverse pregnancy outcomes included maternal death, severe preeclampsia ,eclampsia ,duration of hospital stay and type of care need, mode of delivery ,need of blood transfusion , gestational age during delivary for detet preterm birth early preterm or late preterm from or extremely preterm \\> 28W, birth weigh for low birthweight ,very low birth weight , extremely low birth weight,NICU admission,IUGR, still birth ,abortion, and neonatal death.', 'armGroupLabels': ['CKD PREGNANT PATIENT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed S Mohamedein, Resident', 'role': 'CONTACT', 'email': 'mohamedsaad@med.sohag.edu.eg', 'phone': '01009463244'}, {'name': 'Adel A El sayed, professor', 'role': 'CONTACT', 'phone': '01006677651'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'internal medicine resident in sohag university hospital', 'investigatorFullName': 'Mohamd Saad Mohamedein', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-10', 'type': 'RELEASE'}, {'date': '2024-10-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamd Saad Mohamedein, internal medicine resident in sohag university hospital, Sohag University'}}}}