CKD PREGNANT WOMENNCT05867459
Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
An observational study of CKD PREGNANT WOMEN, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- CKD PREGNANT WOMEN
- What is being tested?
- Serum creatinine, Alb /creat ratio or 24h urine protein and Serum electrolyte
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- All pregnant patients with CKD regardless the cause of CKD in any stage of CKD on dialysis or not.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Adel A El sayed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
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.
Read the 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:
- serum creatinine
- 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
- Conditions
- CKD PREGNANT WOMEN
- Being tested
- Serum creatinine, Alb /creat ratio or 24h urine protein, Serum electrolyte, Urine analysis, Abdominal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum creatinineDiagnostic test
The test wil be measured for all pt in study to detect of their grade of CKD
Alb /creat ratio or 24h urine proteinDiagnostic test
Test will be measured to detect type and sevirity of proteinuria
Serum electrolyteDiagnostic test
The test will be measured in all pt to detect renal tubular state
Urine analysisDiagnostic test
It is mirror of kidney
Abdominal ultrasoundDiagnostic test
To detect the anatomy and any structural abnormality in kidneys
Renal biobsyDiagnostic 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
Clinical assesmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CKD PREGNANT PATIENT | The Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From day of enrollment of pt in study to one week after delivary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CKD PREGNANT WOMENStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamd Saad Mohamedein, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867459
- Sponsor's protocol ID
- Soh-Med-23-04-06MS
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26988973Levey 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.
PubMed 16908915National 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.
PubMed 11904577Hall 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.
PubMed 27350132
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Outcome of CKD Mother Patient in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05867459
- Acronym / sponsor ID
- Soh-Med-23-04-06MS
- Conditions
- CKD PREGNANT WOMEN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- serum creatinine
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD PREGNANT PATIENT | – | 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 assesmentThe Group of pregnant CKD PT as mentioned in introduction and according to KIDOG definition of CKD regardless cause of CKD |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- All pregnant patients with CKD regardless the cause of CKD in any stage of CKD on dialysis or not.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum creatinineThe test wil be measured for all pt in study to detect of their grade of CKD | Diagnostic test | CKD PREGNANT PATIENT |
| Alb /creat ratio or 24h urine proteinTest will be measured to detect type and sevirity of proteinuria | Diagnostic test | CKD PREGNANT PATIENT |
| Serum electrolyteThe test will be measured in all pt to detect renal tubular state | Diagnostic test | CKD PREGNANT PATIENT |
| Urine analysisIt is mirror of kidney | Diagnostic test | CKD PREGNANT PATIENT |
| Abdominal ultrasoundTo detect the anatomy and any structural abnormality in kidneys | Diagnostic test | CKD PREGNANT PATIENT |
| Renal biobsyIs 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 | Diagnostic test | CKD PREGNANT PATIENT |
| Clinical assesmentClinical 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. | Other | CKD PREGNANT PATIENT |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 26988973Cabiddu 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.
- Background: PubMed 16908915Levey 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.
- Background: PubMed 11904577National 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.
- Results publication: PubMed 27350132Hall 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel A El sayed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD PREGNANT WOMEN, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Mohamedein, Resident (01009463244, mohamedsaad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.