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: Recruiting
• Conditions: Chronic Kidney Diseases; Pregnancy Related

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 115

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom
      • Recruiting
      • Elizabeth Ralston
      • Contact: Elizabeth R Ralston; Phone Number: 07713730377; Email: elizabeth.ralston@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with CKD who are planning a pregnancy.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women with Kidney Disease; Women with kidney disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy intention	Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire)	Baseline (Pre-pregnancy)
Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire)	Measuring women's perception of pregnancy risk.	Baseline (Pre-pregnancy)

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Risk perception
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PREDICT_RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No