Improving reproductive health in CKD: a RCT of a pregnancy planning and contraception decision support intervention

The National Institute of Diabetes and Digestive and Kidney Diseases awarded the Regents of the University of Michigan $860,322 on August 1, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to conduct a randomized clinical trial evaluating a web-based decision support tool for reproductive health planning in patients with chronic kidney disease.

The project, titled "Improving Reproductive Health in CKD: A RCT of a Pregnancy Planning and Contraception Decision Support Intervention," will enroll 440 women aged 18–45 with CKD who are not currently attempting to conceive. The intervention, PACE-CKD (Pregnancy and Contraception Education in CKD), is designed to elicit patient values around contraception and pregnancy, deliver tailored information about pregnancy risk based on CKD stage, proteinuria, and other evidence-based risk factors, and support values-based decisions toward CKD-safe contraception and preconception disease optimization. The trial will compare PACE-CKD outcomes against enhanced usual care at nephrology clinics, with the primary objective of decreasing contraceptive non-use and improving informed decision-making among people with CKD. The research addresses the high rate of unplanned or mistimed high-risk pregnancies in this population, where up to 60 percent of women use no contraceptive method and estrogen-containing contraceptives are contraindicated for many patients.

Work is performed in Ann Arbor, Michigan, with a period of performance from August 1, 2026, through May 31, 2031. This is a Project Grant, classified as assistance funding.

Abstract

People with chronic kidney disease (CKD) have a higher likelihood of pregnancy-related complications, including progression of kidney disease, preeclampsia, and preterm birth, and contraceptive use in people with kidney disease is low, with up to 60% of women using no method of contraception. Furthermore, estrogen- containing contraceptives are contraindicated for many people with CKD. Overall, these complex factors lead to a high potential for unplanned or mistimed high-risk pregnancies, contributing to maternal morbidity and mortality in the US, and underscoring the need to improve contraceptive and preconception care for people with CKD. Guided by the health belief model and the ottawa decision support framework, we developed and pilot-tested a novel decision-support tool (pregnancy and contraception education in CKD, or pace-CKD) to elicit CKD patient values around contraception and pregnancy, deliver tailored information about pregnancy risk based on CKD stage, proteinuria, and other evidence-based risk factors, and culminate with actionable, values-based next steps towards CKD-safe contraception and pre-conception disease optimization. The long- term goal of this research is to support family planning goals for all patients with CKD, to achieve the healthiest possible pregnancies when desired and to decrease unintended or mistimed pregnancies leading to significant adverse immediate and long-term outcomes. The objective of this proposal, in pursuit of the overall goal, is to examine the impact of the novel web-based decision aid at decreasing contraceptive non-use and improving informed decision-making among people with CKD. To accomplish this, we will enroll 440 women 18-45 years old with CKD who are not currently trying to conceive in a randomized clinical trial of the decision aid, pace- CKD, versus enhanced usual care at nephrology clinics at 5 institutions to: aim 1: assess the efficacy of pace-CKD on contraceptive non-use by patient report at 6-months post-enrollment (primary outcome), as well as on contraceptive method satisfaction and effectiveness (use of methods with