Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate

NCT05867459 | Unknown

• 1 other identifier: Soh-Med-23-04-06MS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD PREGNANT WOMEN

Outcome Measures

Primary Outcomes (1)

• 1) the pregnancy outcomes of patients with CKD (2) additional risk factors for adverse pregnancy outcomes in patients with CKD

  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

  From day of enrollment of pt in study to one week after delivary

Study Arms (1)

CKD PREGNANT PATIENT

The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD

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

Interventions

Serum creatinine DIAGNOSTIC_TEST

The test wil be measured for all pt in study to detect of their grade of CKD

CKD PREGNANT PATIENT

Alb /creat ratio or 24h urine protein DIAGNOSTIC_TEST

Test will be measured to detect type and sevirity of proteinuria

CKD PREGNANT PATIENT

Serum electrolyte DIAGNOSTIC_TEST

The test will be measured in all pt to detect renal tubular state

CKD PREGNANT PATIENT

Urine analysis DIAGNOSTIC_TEST

It is mirror of kidney

CKD PREGNANT PATIENT

Abdominal ultrasound DIAGNOSTIC_TEST

To detect the anatomy and any structural abnormality in kidneys

CKD PREGNANT PATIENT

Renal biobsy DIAGNOSTIC_TEST

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

CKD PREGNANT PATIENT

Clinical assesment OTHER

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.

CKD PREGNANT PATIENT

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 26988973 BACKGROUND

• 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.

  PMID: 16908915 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

• 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.

  PMID: 27350132 RESULT

MeSH Terms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Central Study Contacts

Mohamed S Mohamedein, Resident

CONTACT

01009463244; mohamedsaad@med.sohag.edu.eg

Adel A El sayed, professor

CONTACT

01006677651

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: internal medicine resident in sohag university hospital

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

EG (1)