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PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease (PREDICT_RP)

K

King's College London

Status

Unknown

Conditions

Chronic Kidney Diseases
Pregnancy Related

Study type

Observational

Funder types

Other

Identifiers

NCT04370769
PREDICT_RP

Details and patient eligibility

About

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.

Full 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

Enrollment

115 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

115 participants in 1 patient group

Women with Kidney Disease
Description:
Women with kidney disease

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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