Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate

May 10, 2023 updated by: Mohamd Saad Mohamedein, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adel A El sayed, professor
  • Phone Number: 01006677651

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The test wil be measured for all pt in study to detect of their grade of CKD
Diagnostic test: Alb /creat ratio or 24h urine protein
Test will be measured to detect type and sevirity of proteinuria
Diagnostic test: Serum electrolyte
The test will be measured in all pt to detect renal tubular state
Diagnostic test: Urine analysis
It is mirror of kidney
Diagnostic test: Abdominal ultrasound
To detect the anatomy and any structural abnormality in kidneys
Diagnostic test: Renal biobsy
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
Other: Clinical assesment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1) the pregnancy outcomes of patients with CKD (2) additional risk factors for adverse pregnancy outcomes in patients with CKD
Time Frame: 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
From day of enrollment of pt in study to one week after delivary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-23-04-06MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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