PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease

NCT ID: NCT04370769

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2022-03-31

Brief 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.

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

Conditions

Chronic Kidney Diseases; Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Women with Kidney Disease

Women with kidney disease

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elizabeth Ralston

London, Greater London, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Elizabeth R Ralston

Role: primary

elizabeth.ralston@kcl.ac.uk

07713730377

References

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.

Reference Type: DERIVED

PMID: 36971978 (View on PubMed)

Other Identifiers

PREDICT_RP

Identifier Type: -

Identifier Source: org_study_id