Chronic Kidney Disease in Pregnant Females

NCT ID: NCT06738069

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 497 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2029-12-31

Brief Summary

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

Conditions

CKD

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Participants are not assigned an intervention as a part of the study

Interventions

Participants are not assigned an intervention as a part of the study

Participants are not assigned an intervention as a part of the study

Intervention Type: OTHER

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Makram Ibrahim Ahmed

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rehab Makram Ibrahim, Doctor

Role: CONTACT

Phone: +201014828702

Email: roobroba@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 38273240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32775838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35529086 (View on PubMed)

Vinturache A, Khalil A, Glob. Libr. Women's me d., ISSN: 1756-2228; DOI 10.3843/GLOWM.411323

Reference Type: BACKGROUND

Other Identifiers

CKD in pregnancy

Identifier Type: -

Identifier Source: org_study_id