Chronic Kidney Disease in Pregnant Females
December 13, 2024 updated by: Rehab Makram Ibrahim Ahmed, Assiut University
Frequency of Chronic Kidney Disease Among Pregnant Women At Assuit University Hospitals
Screening of Chronic Kidney Disease among pregnant women for early detection
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
497
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: Rehab Makram Ibrahim, Doctor
- Phone Number: +201014828702
- Email: roobroba@gmail.com
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
Non-Probability Sample
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.
Description
Inclusion Criteria:
- -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
Exclusion Criteria:
- Pregnant women who are known CKD.
- Pregnant women refuse to participate with this study .
- Pregnant women with Acute Kidney Injury .
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 |
|---|---|
|
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
|
Participants are not assigned an intervention as a part of the study
|
|
Healthy pregnant female
Pregnant female without ckd and Alb /Cr ratio was negative
|
Participants are not assigned an intervention as a part of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Through study completion, an average of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Kovesdy 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.
- 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.
- Maule 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.
- Vinturache A, Khalil A, Glob. Libr. Women's me d., ISSN: 1756-2228; DOI 10.3843/GLOWM.411323
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 (Estimated)
December 1, 2024
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
December 13, 2024
First Submitted That Met QC Criteria
December 13, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 13, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKD in pregnancy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.