NCT06738069

Brief Summary

Screening of Chronic Kidney Disease among pregnant women for early detection

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Dec 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2024Dec 2029

Study Start

First participant enrolled

December 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 17, 2024

Status Verified

September 1, 2024

Enrollment Period

3.8 years

First QC Date

December 13, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Through study completion, an average of 3 years

Study Arms (2)

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

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

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

Healthy pregnant femalePregnant female with CKD

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women who are known CKD.
  • Pregnant women refuse to participate with this study .
  • Pregnant women with Acute Kidney Injury .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 38273240BACKGROUND
  • 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.

    PMID: 32775838BACKGROUND
  • 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.

    PMID: 35529086BACKGROUND
  • Vinturache A, Khalil A, Glob. Libr. Women's me d., ISSN: 1756-2228; DOI 10.3843/GLOWM.411323

    BACKGROUND

Central Study Contacts

Rehab Makram Ibrahim, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 17, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

December 17, 2024

Record last verified: 2024-09