PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease

Pregnancy Related Clinical Trial

— PREDICT_RP  

Official title:

Understanding Perception of Risk in Pregnancy Associated Progression of Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04370769
• Other study ID #: PREDICT_RP
• Status: Recruiting
• Start date: October 16, 2020
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

The objectives for this research are:

1. To understand how women with CKD perceive their pregnancy risk.

2. To examine the associations between biopsychosocial factors (demographics, psychosocial factors, renal and pregnancy history) and women with CKD's perception of risk in pregnancy.

3. To examine the relationship between pregnancy-related intention and perception of pregnancy risk in women with CKD.

4. 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Pregnancy Related
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United Kingdom	Elizabeth Ralston	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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)