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Pregnancy and Contraception Education for Chronic Kidney Disease (PACE-CKD Trial)

N/A
Recruiting
Led By Andrea Oliverio, MD, MSc
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any Chronic Kidney Disease (CKD) diagnosis
Be between 18 and 65 years old
Must not have
Patients who have a kidney transplant
Patients that are surgically sterile (tubal ligation or hysterectomy) or currently pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is a small study that aims to test a tool that helps patients with chronic kidney disease make decisions about pregnancy and contraception. The study will also look at how well the tool works and if patients

Who is the study for?
This trial is for patients with chronic kidney disease who are interested in making informed decisions about their reproductive health. Specific eligibility criteria have not been provided, but typically such trials require participants to be adults capable of consent and without conditions that might interfere with the study.
What is being tested?
The study is testing a special decision aid designed to help kidney disease patients understand their options regarding pregnancy and contraception. This will be compared to standard informational handouts. The goal is to see if the decision aid improves understanding and decision-making.
What are the potential side effects?
Since this trial involves educational materials rather than medical treatments, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a kidney transplant.
Select...
I am either surgically sterile or currently pregnant.
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I am currently on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Preparation for Decision Making (PrepDM) score at post-intervention
Secondary study objectives
Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants
Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists
Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention Group - Decision aidExperimental Treatment1 Intervention
Group II: Control Group -Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decision aid
2018
N/A
~17810

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,349 Total Patients Enrolled
University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,991 Total Patients Enrolled
Andrea Oliverio, MD, MScPrincipal InvestigatorUniversity of Michigan
~13 spots leftby Feb 2025
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