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Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate

S

Sohag University

Status

Enrolling

Conditions

CKD PREGNANT WOMEN

Treatments

Diagnostic Test: Alb /creat ratio or 24h urine protein
Diagnostic Test: Serum creatinine
Diagnostic Test: Abdominal ultrasound
Diagnostic Test: Renal biobsy
Diagnostic Test: Urine analysis
Diagnostic Test: Serum electrolyte
Other: Clinical assesment

Study type

Observational

Funder types

Other

Identifiers

NCT05867459
Soh-Med-23-04-06MS

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 52 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

30 participants in 1 patient group

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
Treatment:
Other: Clinical assesment
Diagnostic Test: Serum electrolyte
Diagnostic Test: Renal biobsy
Diagnostic Test: Alb /creat ratio or 24h urine protein
Diagnostic Test: Abdominal ultrasound
Diagnostic Test: Serum creatinine
Diagnostic Test: Urine analysis

Trial contacts and locations

1

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Central trial contact

Adel A El sayed, professor; Mohamed S Mohamedein, Resident

Data sourced from clinicaltrials.gov

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