- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370769
PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease (PREDICT_RP)
Understanding Perception of Risk in Pregnancy Associated Progression of Chronic Kidney Disease
Currently, there is no robust evidence about how women with Chronic Kidney Disease (CKD) perceive pregnancy risk. The aims of this research are to understand women with CKD's perception of risk in pregnancy. In order to provide appropriate pre-pregnancy and antenatal counselling including accurate presentation of risk of pregnancy outcomes, it is important to establish how do women with CKD perceive their risk in pregnancy. In addition, to facilitate discussion about pregnancy for women with CKD, it is critical to understand key psychosocial factors influencing their risk perceptions.
This study will be conducted in two phases. In phase one, risk perceptions in women with CKD who are contemplating pregnancy will be quantitatively measured with potential influencing psychosocial factors including their illness perceptions, quality of life, anxiety, depression and perceived social support. Demographic, pregnancy-intentions, medical and pregnancy histories will also be collected. Phase one findings will establish to what extent do women with CKD perceive their pregnancy risk.
In phase two, perception of risk, pregnancy intention and behaviour, will be qualitatively explored in women with CKD who perceive high and low degrees of risk. This sub-study will facilitate understanding about which factors and experiences impact risk perception and their relationship with pregnancy intentions and behaviour.
Study Overview
Status
Conditions
Detailed Description
The objectives for this research are:
- To understand how women with CKD perceive their pregnancy risk.
- To examine the associations between biopsychosocial factors (demographics, psychosocial factors, renal and pregnancy history) and women with CKD's perception of risk in pregnancy.
- To examine the relationship between pregnancy-related intention and perception of pregnancy risk in women with CKD.
- To gain an in-depth understanding of the biopsychosocial factors which influence risk perception and pregnancy-related behaviour, in women with CKD who perceive high and low risk perceptions.
To achieve these objectives this study is divided into two phases:
Phase 1: Quantitative assessment of risk perception and biopsychosocial factors in women with CKD Phase 2: Qualitative exploration of risk perception in women with CKD with high and low risk perception scores
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Greater London
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London, Greater London, United Kingdom
- Recruiting
- Elizabeth Ralston
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Contact:
- Elizabeth R Ralston
- Phone Number: 07713730377
- Email: elizabeth.ralston@kcl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosed with CKD stages 1-5 according to KDOQI guidelines)
- ≥18 years old
- Planning a pregnancy
- Adults who have the capacity/capability to provide fully informed consent for the study
Exclusion Criteria:
- Already established on haemodialysis or peritoneal dialysis
- Women < 18 years old or >50 years old
- Inability or unwilling to give informed consent
- Does not speak English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Women with Kidney Disease
Women with kidney disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy intention
Time Frame: Baseline (Pre-pregnancy)
|
Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire)
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Baseline (Pre-pregnancy)
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Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire)
Time Frame: Baseline (Pre-pregnancy)
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Measuring women's perception of pregnancy risk.
|
Baseline (Pre-pregnancy)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREDICT_RP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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