Chronic Kidney DiseasesPREDICT_RPNCT04370769
PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease
An observational study of Chronic Kidney Diseases and Pregnancy Related, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chronic Kidney Diseases, Pregnancy Related
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with CKD who are planning a pregnancy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Elizabeth Ralston
London, Greater London
Elizabeth R Ralston, 07713730377, elizabeth.ralston@kcl.ac.uk
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Kidney Diseases, Pregnancy Related
- Keywords
- Risk perception
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Kidney Disease | Women with kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy intention
Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire)
Measured: Baseline (Pre-pregnancy)
Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire)
Measuring women's perception of pregnancy risk.
Measured: Baseline (Pre-pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start16 Oct 2020
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370769
- Sponsor's protocol ID
- PREDICT_RP
- Acronym
- PREDICT_RP
- Status last verified
- Sep 2021
- First submitted
- 29 Apr 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ralston ER, Smith P, Clark K, Wiles K; RaDaR CKD Pregnancy Group; Chilcot J, Bramham K. Exploring biopsychosocial correlates of pregnancy risk and pregnancy intention in women with chronic kidney disease. J Nephrol. 2023 Jun;36(5):1361-1372. doi: 10.1007/s40620-023-01610-2. Epub 2023 Mar 27.
PubMed 36971978
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Perception of Risk in Pregnancy Associated Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04370769
- Acronym / sponsor ID
- PREDICT_RP / PREDICT_RP
- Conditions
- Chronic Kidney Diseases, Pregnancy Related
- Keywords
- Risk perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Kidney Disease | – | –Women with kidney disease |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with CKD who are planning a pregnancy.
Key inclusion criteria (4 listed)
- Diagnosed with CKD stages 1-5 according to KDOQI guidelines)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy intention
Time frame: Baseline (Pre-pregnancy)
Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire)
Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire)
Time frame: Baseline (Pre-pregnancy)
Measuring women's perception of pregnancy risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 36971978Ralston ER, Smith P, Clark K, Wiles K; RaDaR CKD Pregnancy Group; Chilcot J, Bramham K. Exploring biopsychosocial correlates of pregnancy risk and pregnancy intention in women with chronic kidney disease. J Nephrol. 2023 Jun;36(5):1361-1372. doi: 10.1007/s40620-023-01610-2. Epub 2023 Mar 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Pregnancy Related, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy intention (time frame: Baseline (Pre-pregnancy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.