Clinical trial NCT05867459: Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
Official title: Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD PREGNANT WOMEN
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
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.
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.
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.
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.