PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease

NCT04370769 | Unknown

• 1 other identifier: PREDICT_RP
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Pregnancy Related

Keywords

Risk perception

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Women with Kidney Disease

Women with kidney disease

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with CKD who are planning a pregnancy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Elizabeth Ralston

London, Greater London, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36971978 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: October 16, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)