Pregnancy Related Clinical Trial
— PREDICT_RPOfficial title:
Understanding Perception of Risk in Pregnancy Associated Progression of Chronic Kidney Disease
NCT number | NCT04370769 |
Other study ID # | PREDICT_RP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 16, 2020 |
Est. completion date | March 2022 |
Verified date | September 2021 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 115 |
Est. completion date | March 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Elizabeth Ralston | London | Greater London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy intention | Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire) | Baseline (Pre-pregnancy) | |
Primary | Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire) | Measuring women's perception of pregnancy risk. | Baseline (Pre-pregnancy) |
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