Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate

Recruiting

• Conditions: CKD PREGNANT WOMEN
• Interventions: 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

• Registration Number: NCT05867459
• Lead Sponsor: Sohag University

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• All pregnant patients with CKD regardless the cause of CKD in any stage of CKD on dialysis or not.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD PREGNANT PATIENT	Alb /creat ratio or 24h urine protein	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Serum electrolyte	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Clinical assesment	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Serum creatinine	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Renal biobsy	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Urine analysis	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD
CKD PREGNANT PATIENT	Abdominal ultrasound	The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD

Primary Outcome Measures

Name	Time	Method
1) the pregnancy outcomes of patients with CKD (2) additional risk factors for adverse pregnancy outcomes in patients with CKD	From day of enrollment of pt in study to one week after delivary	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 .; duration 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.; And questionaire of pt for risk factor as DM,HTN,maternal age,drug use during delivary, stage of CKD

Trial Locations

Locations (1)

Sohag university hospital; 🇪🇬 Sohag, Egypt