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:
Sohag University
Organization:
Study Overview
Official Title:
Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the work:
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.
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.
Detailed Description:
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 .
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: