Pregnancy and Contraception Education for Chronic Kidney Disease

(PACE-CKD Trial)

Overseen By Kelcie Brophy

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dialysis, Kidney transplant, Surgically sterile, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with chronic kidney disease (CKD) in making informed decisions about pregnancy and contraception. Participants will either use a specially designed education tool, the Pregnancy and Contraception Education Decision Aid, or join a control group to evaluate the tool's effectiveness. The trial seeks individuals with CKD who do not require dialysis or have undergone a kidney transplant and who can read and speak English. Those with CKD considering reproductive health options may find this study suitable. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that may enhance decision-making tools for CKD patients considering reproductive health options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid is safe for patients with chronic kidney disease?

Research has shown that the Pregnancy and Contraception Education Decision Aid primarily serves as an educational tool. It assists individuals with chronic kidney disease in making informed decisions about pregnancy and contraception. As it is not a drug or medical device, specific safety data like that for medications does not exist.

The decision aid aims to guide patients with personalized reproductive health information. Being educational, it does not carry the same risks as medical treatments, and there are no known side effects from its use. Its success is measured by how effectively it helps patients understand their options and make informed decisions.

In summary, the decision aid is considered safe because it provides information rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pregnancy and Contraception Education Decision Aid for chronic kidney disease because it offers a personalized approach to education that current standard options, like general counseling, may lack. This decision aid is designed to provide tailored information that aligns with the unique needs and concerns of individuals with chronic kidney disease. By focusing on personalized education, researchers hope to empower patients with the knowledge to make informed decisions about pregnancy and contraception, potentially improving patient outcomes and satisfaction.

What evidence suggests that the Pregnancy and Contraception Education Decision Aid is effective for chronic kidney disease patients?

Research shows that women with chronic kidney disease (CKD) face serious risks during pregnancy and often lack adequate advice on birth control. Studies indicate that 46% of pregnancies in women with advanced CKD stages worsen their kidney disease. This highlights the need for improved guidance on reproductive health. In this trial, participants in the intervention group will use a tool designed to educate about pregnancy and contraception, helping women make informed choices. Early evidence suggests that these tools can enhance understanding and decision-making about reproductive health for women with CKD. ^{1 2 4 5 6}

Who Is on the Research Team?

Andrea Oliverio, MD, MSc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for patients with chronic kidney disease who are interested in making informed decisions about their reproductive health. Specific eligibility criteria have not been provided, but typically such trials require participants to be adults capable of consent and without conditions that might interfere with the study.

Inclusion Criteria

Able to speak and read English

I have been diagnosed with chronic kidney disease.

I have kidney problems for more than 3 months.

Exclusion Criteria

I have had a kidney transplant.

Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)

I am either surgically sterile or currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a novel decision aid about pregnancy and contraception in chronic kidney disease or currently available educational materials

1 day

1 visit (in-person)

Follow-up

Participants complete a survey about pregnancy and contraception decision making and the acceptability and feasibility of the educational materials

1 week

1 visit (virtual)

Long-term Follow-up

Nephrologists are anonymously surveyed after all patients have completed measures to assess acceptability and feasibility

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pregnancy and Contraception Education Decision Aid

Trial Overview The study is testing a special decision aid designed to help kidney disease patients understand their options regarding pregnancy and contraception. This will be compared to standard informational handouts. The goal is to see if the decision aid improves understanding and decision-making.

How Is the Trial Designed?

Group I: Intervention Group - Decision aid Experimental Treatment 1 Intervention

Group II: Control Group - Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Women of childbearing age with chronic kidney disease (CKD) often receive inconsistent and inadequate reproductive counseling, particularly regarding pregnancy options.

There is a need for comprehensive reproductive counseling for these women, as well as more rigorous research on pregnancy outcomes in those with CKD, including those on dialysis or post-kidney transplant, to enhance informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ignorance is Not Bliss: The Case for Comprehensive Reproductive Counseling for Women with Chronic Kidney Disease. Iltis, AS., Mehta, M., Sawinski, D.[2023]

A new decision aid, consisting of a 50-minute video and an informational handbook, was developed to help patients with end-stage renal disease (ESRD) and their families understand treatment options for renal replacement therapy (RRT).

Preliminary evaluations showed that the materials were well-received and comprehensible, with the handbook written at a 4th to 6th grade reading level, making it accessible for patients with varying health literacy and cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. Ameling, JM., Auguste, P., Ephraim, PL., et al.[2021]

Only 56% of healthcare professionals used patient decision aids like 'Three Good Questions' and the Dutch Kidney Guide during kidney failure treatment education, indicating limited implementation of these tools.

Patients reported higher satisfaction with their education in hospitals that utilized these decision aids, but their experience of shared decision-making did not improve after healthcare professionals received training on these aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of patient decision aids for shared decision-making in kidney failure. van Eck van der Sluijs, A., Vonk, S., Bonenkamp, AA., et al.[2023]

A study involving 100 older patients with advanced chronic kidney disease (CKD) found that both verbal and video education significantly increased knowledge of supportive kidney care, but there was no difference in effectiveness between the two methods.

Despite the lack of difference in knowledge or preferences for supportive kidney care between the education types, the video decision aid was highly accepted, with 96% of participants feeling comfortable with it and finding it helpful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. Eneanya, ND., Percy, SG., Stallings, TL., et al.[2021]

Women of childbearing age with kidney disease should receive proactive counseling about pregnancy and contraception, focusing on how pregnancy can affect their kidney health and vice versa.

Nephrologists often overlook important topics such as sexual dysfunction, infertility, and menstrual irregularities in discussions with premenopausal women patients, highlighting a gap in comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and contraceptive counseling of women with chronic kidney disease and kidney transplants. Watnick, S.[2022]

Patients with end-stage renal disease can choose and change their treatment options, making the way information is presented crucial for their decision-making process.

Using structured 'patient decision aids' that follow simple principles can help patients make informed choices about dialysis options, leading to better treatment compliance and improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to select among dialysis options. Mooney, A.[2019]

A study involving 30 female patients with chronic kidney disease (CKD) and 12 nephrologists revealed a significant gap in reproductive health counseling, with patients expressing a strong desire for nephrologists to initiate discussions about reproductive health during kidney clinic visits.

Both patients and nephrologists identified the need for improved risk communication, with patients wanting a balance of risks and benefits while nephrologists focused on providing individualized risk estimates, highlighting the importance of tailored communication in reproductive counseling for CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Patient-Centered Pregnancy Counseling in Nephrology Care: A Semistructured Interview Study of Patients and Nephrologists. Oliverio, AL., Lewallen, M., Hladunewich, MA., et al.[2023]

Women with chronic kidney disease (CKD) face significant challenges in achieving parenthood due to medical complexities and increased risks for both mother and baby during pregnancy.

Understanding the patient perspective is crucial for effective counseling and shared decision-making, which can enhance the overall experience for women with CKD considering pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient experience of kidney disease and pregnancy. Jesudason, S., Tong, A.[2020]

Women with kidney disease often feel that their reproductive health needs are overlooked, leading to challenges in family planning and unmet health needs, which can negatively impact their relationships and life goals.

There is a significant lack of shared decision-making in healthcare regarding reproductive health for these women, highlighting the need for tailored interventions that empower them to make informed choices about pregnancy and parenting options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feminizing care pathways: Mixed-methods study of reproductive options, decision making, pregnancy, post-natal care and parenting amongst women with kidney disease. Mc Laughlin, L., Jones, C., Neukirchinger, B., et al.[2023]

Women with chronic kidney disease (CKD) can conceive and deliver successfully, but effective birth control is crucial to prevent unwanted pregnancies that could have serious health implications.

Personalized contraception options, including progestin-only methods and non-medicated intrauterine devices, are generally safe for women with CKD, and should be actively discussed and offered to those of childbearing age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraception in chronic kidney disease: a best practice position statement by the Kidney and Pregnancy Group of the Italian Society of Nephrology. Attini, R., Cabiddu, G., Montersino, B., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06189807

Pregnancy and Contraception Education in Chronic Kidney ... This pilot study will assess the efficacy of a pregnancy and contraception education decision aid (DA) for patients with chronic kidney disease to support ...

2. withpower.com withpower.com/trial/pregnancy-and-contraception-education-for-chronic-kidney-disease-3e6f7

Pregnancy and Contraception Education for Chronic Kidney ... This pilot study will assess the efficacy of a pregnancy and contraception education decision aid (DA) for patients with chronic kidney disease to support ...

3. ajkd.org ajkd.org/article/S0272-6386(25)01019-4/fulltext

Contraceptive Use and Reproductive Health in Women ... Women with chronic kidney disease (CKD) face elevated risks during pregnancy, yet contraceptive use and reproductive health counseling ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11616362/

CKD in reproductive-aged women: a call for early ... Recent data from United Kingdom reveal that 46% of pregnancies in women with CKD stages 3–5 had kidney disease progression -defined as at least ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0272638625010194

Contraceptive Use and Reproductive Health in Women ... Women with chronic kidney disease (CKD) face elevated risks during pregnancy, yet contraceptive use and reproductive health counseling remain ...

6. ctv.veeva.com ctv.veeva.com/study/pregnancy-and-contraception-education-in-chronic-kidney-disease-pace-ckd

Pregnancy and Contraception Education in Chronic Kidney ... This pilot study will assess the efficacy of a pregnancy and contraception education decision aid (DA) for patients with chronic kidney disease to support ...