Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
NCT ID: NCT05867459
Last Updated: 2023-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2023-04-01
2023-12-31
Brief Summary
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In this study, we aimed:
Is 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.
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Detailed Description
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The 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
Duration of study:
nine month after approval of protocol by medical research committee of sohag faculty of medicine
Data collection procedure:
The following clinical data will be collected:
Clinical assessment:
age, 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)
Evaluation 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.
Laboratory assessment:
1. serum creatinine
2. urine analysis 3-24h protein in urine or albumin create ratio
4-serum electrolyte s.Na s.K ionezed Ca 5-pathological result of renal biopsy if done 6-abdominal ultrasound with full comment on kidney
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CKD PREGNANT PATIENT
The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
Serum creatinine
The test wil be measured for all pt in study to detect of their grade of CKD
Alb /creat ratio or 24h urine protein
Test will be measured to detect type and sevirity of proteinuria
Serum electrolyte
The test will be measured in all pt to detect renal tubular state
Urine analysis
It is mirror of kidney
Abdominal ultrasound
To detect the anatomy and any structural abnormality in kidneys
Renal biobsy
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
Clinical assesment
Clinical assessment:
age, 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)
Evaluation 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.
Interventions
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Serum creatinine
The test wil be measured for all pt in study to detect of their grade of CKD
Alb /creat ratio or 24h urine protein
Test will be measured to detect type and sevirity of proteinuria
Serum electrolyte
The test will be measured in all pt to detect renal tubular state
Urine analysis
It is mirror of kidney
Abdominal ultrasound
To detect the anatomy and any structural abnormality in kidneys
Renal biobsy
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
Clinical assesment
Clinical assessment:
age, 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)
Evaluation 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
52 Years
FEMALE
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Mohamd Saad Mohamedein
internal medicine resident in sohag university hospital
Locations
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Sohag university hospital
Sohag, , Egypt
Countries
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Central Contacts
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Adel A El sayed, professor
Role: CONTACT
Facility Contacts
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Magdy M Amin, Professor
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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Soh-Med-23-04-06MS
Identifier Type: -
Identifier Source: org_study_id
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