CKDNCT06738069
Chronic Kidney Disease in Pregnant Females
An observational study of CKD, run by Assiut University.
Trial summary
Screening of Chronic Kidney Disease among pregnant women for early detection Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- CKD
- What is being tested?
- Participants are not assigned an intervention as a part of the study
- How many people
- 497 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of pregnant women aged 18 years and older who present to Assiut University Hospitals for routine antenatal care or are admitted for delivery. We will include women from all trimesters of pregnancy who can provide informed consent. Exclusion criteria will encompass those with a diagnosis of acute kidney injury, a history of kidney transplantation, or chronic conditions that may confound CKD assessment unless specifically included in the study. We aim to recruit a total coverage for one year from October 2024 to September 2025. This study will provide valuable insights into the frequency of chronic kidney disease among pregnant women in this setting.
Who may be able to join
- -all pregnant women at antenatal care who came to Outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals
- At age of 18 yrs old or above . -Who accept to participate with this study
Who cannot join
- Pregnant women who are known CKD.
- Pregnant women refuse to participate with this study .
- Pregnant women with Acute Kidney Injury .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Frequency of Chronic Kidney Disease Among Pregnant Women at Assuit University Hospitals
Screening of Chronic Kidney Disease among pregnant women for early detection
Read the detailed description
Normal pregnancy associated with plasma volume expansion and hormonal changes lead to an increase in GFR of 40% to 65% in first and second trimester , with decrease in GFR of approximately 15% to 20% in the third trimester . Chronic Kidney Disease (CKD) is defined as abnormalities of kidney structure or function, present for a minimum of 3 months, with significant health implications .CKD classification is based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3), abbreviated as CGA . CKD during pregnancy is a major health concern ,affecting up to 3% of women of reproductive age in high-income countries, but estimated prevalence may be as much as 50% higher in low and middle-income countries (LMICs). Pregnant women with CKD at high risk of adverse maternal and fetal outcome , including hypertension development or worsening ,Preeclampsia, eclampsia , Anemia , platelets abnormalities , worsening kidney function ,need for cesarean section ,Pregnancy loss ,stillbirth ,Preterm labor ,Intrauterine growth restriction . CKD if detected and treated early in its course, ESRD is often preventable, especially for high risk individuals. CKD is often unrecognizable and asymptomatic until it is in its later stages, when the chances of preventing kidney failure are limited. Therefore, in order to administer targeted therapeutic interventions . early identification and stratification of those at highest risk of CKD are urgently needed. Screening programs using state of the art point-of-care testing equipment with blood and urine samples can test for CKD both quickly and accurately
- Conditions
- CKD
- Being tested
- Participants are not assigned an intervention as a part of the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are not assigned an intervention as a part of the studyOther
Participants are not assigned an intervention as a part of the study
| Study group | Role | What they receive |
|---|---|---|
| Pregnant female with CKD | Pregnant female Newly discovered as chronic kidney disease by our study.inclusion criteria including age 18 or above who accept to precipitate this study.. exclusion criteria including female actually known as CKD and female refusing to precipitate in our study... this female confirmed as CKD by positive Alb/Cr ratio in 2 occasions with 3 months duration in between | |
| Healthy pregnant female | Pregnant female without ckd and Alb /Cr ratio was negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CKD among pregnant women attending antenatal care who came to outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals
Measured: Through study completion, an average of 3 years
Secondary outcomes (1)
Causes of CKD among pregnant women attending antenatal care who came to Outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at assuit University Hospitals
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2029 (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 CKDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 497 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Makram Ibrahim Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738069
- Sponsor's protocol ID
- CKD in pregnancy
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farrell DR, Vassalotti JA. Screening, identifying, and treating chronic kidney disease: why, who, when, how, and what? BMC Nephrol. 2024 Jan 25;25(1):34. doi: 10.1186/s12882-024-03466-5.
PubMed 38273240Maule SP, Ashworth DC, Blakey H, Osafo C, Moturi M, Chappell LC, Bramham K, Milln J. CKD and Pregnancy Outcomes in Africa: A Narrative Review. Kidney Int Rep. 2020 May 26;5(8):1342-1349. doi: 10.1016/j.ekir.2020.05.016. eCollection 2020 Aug.
PubMed 32775838Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.
PubMed 35529086Vinturache A, Khalil A, Glob. Libr. Women's me d., ISSN: 1756-2228; DOI 10.3843/GLOWM.411323
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Chronic Kidney Disease Among Pregnant Women at Assuit University Hospitals
- ClinicalTrials.gov ID
- NCT06738069
- Acronym / sponsor ID
- CKD in pregnancy
- Conditions
- CKD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 497 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Dec 2024 (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.
Screening of Chronic Kidney Disease among pregnant women for early detection
Detailed description
Normal pregnancy associated with plasma volume expansion and hormonal changes lead to an increase in GFR of 40% to 65% in first and second trimester , with decrease in GFR of approximately 15% to 20% in the third trimester . Chronic Kidney Disease (CKD) is defined as abnormalities of kidney structure or function, present for a minimum of 3 months, with significant health implications .CKD classification is based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3), abbreviated as CGA . CKD during pregnancy is a major health concern ,affecting up to 3% of women of reproductive age in high-income countries, but estimated prevalence may be as much as 50% higher in low and middle-income countries (LMICs). Pregnant women with CKD at high risk of adverse maternal and fetal outcome , including hypertension development or worsening ,Preeclampsia, eclampsia , Anemia , platelets abnormalities , worsening kidney function ,need for cesarean section ,Pregnancy loss ,stillbirth ,Preterm labor ,Intrauterine growth restriction . CKD if detected and treated early in its course, ESRD is often preventable, especially for high risk individuals. CKD is often unrecognizable and asymptomatic until it is in its later stages, when the chances of preventing kidney failure are limited. Therefore, in order to administer targeted therapeutic interventions . early identification and stratification of those at highest risk of CKD are urgently needed. Screening programs using state of the art point-of-care testing equipment with blood and urine samples can test for CKD both quickly and accurately
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant female with CKD | – | –Pregnant female Newly discovered as chronic kidney disease by our study.inclusion criteria including age 18 or above who accept to precipitate this study.. exclusion criteria including female actually known as CKD and female refusing to precipitate in our study... this female confirmed as CKD by positive Alb/Cr ratio in 2 occasions with 3 months duration in between |
| Healthy pregnant female | – | –Pregnant female without ckd and Alb /Cr ratio was negative |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of pregnant women aged 18 years and older who present to Assiut University Hospitals for routine antenatal care or are admitted for delivery. We will include women from all trimesters of pregnancy who can provide informed consent. Exclusion criteria will encompass those with a diagnosis of acute kidney injury, a history of kidney transplantation, or chronic conditions that may confound CKD assessment unless specifically included in the study. We aim to recruit a total coverage for one year from October 2024 to September 2025. This study will provide valuable insights into the frequency of chronic kidney disease among pregnant women in this setting.
Key inclusion criteria (2 listed)
- -all pregnant women at antenatal care who came to Outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals
- At age of 18 yrs old or above . -Who accept to participate with this study
Key exclusion criteria (3 listed)
- Pregnant women who are known CKD.
- Pregnant women refuse to participate with this study .
- Pregnant women with Acute Kidney Injury .
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 |
|---|---|---|
| Participants are not assigned an intervention as a part of the studyParticipants are not assigned an intervention as a part of the study | Other | – |
Primary outcome
Percentage of CKD among pregnant women attending antenatal care who came to outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals
Time frame: Through study completion, an average of 3 years
1 secondary outcome
Causes of CKD among pregnant women attending antenatal care who came to Outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at assuit University Hospitals
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Results publication: PubMed 38273240Farrell DR, Vassalotti JA. Screening, identifying, and treating chronic kidney disease: why, who, when, how, and what? BMC Nephrol. 2024 Jan 25;25(1):34. doi: 10.1186/s12882-024-03466-5.
- Results publication: PubMed 32775838Maule SP, Ashworth DC, Blakey H, Osafo C, Moturi M, Chappell LC, Bramham K, Milln J. CKD and Pregnancy Outcomes in Africa: A Narrative Review. Kidney Int Rep. 2020 May 26;5(8):1342-1349. doi: 10.1016/j.ekir.2020.05.016. eCollection 2020 Aug.
- Results publication: PubMed 35529086Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.
- Results publicationVinturache A, Khalil A, Glob. Libr. Women's me d., ISSN: 1756-2228; DOI 10.3843/GLOWM.411323
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CKD
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.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD, run by Assiut University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehab Makram Ibrahim, Doctor (+201014828702, roobroba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CKD among pregnant women attending antenatal care who came to outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals (time frame: Through study completion, an average of 3 years). 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 NCT06738069, 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 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.