Summary

for females ages 18-50 (full criteria)
healthy people welcome
at La Jolla, California
study started
estimated completion
Sheila Mody

Description

Summary

The purpose of this study is to use an electronic survey to explore Solid Organ Transplant patients' contraceptive knowledge and counseling. The results from this survey will be used to help identify awareness gaps to potentially develop targeted interventions for comprehensive education.

Details

According to data from the U.S. Organ Procurement and Transplantation Network, 10,804 women received organ transplants in 2011. Of these women, 3896 (36%) were between the ages of 18 and 49. Women of reproductive age make up a significant part of the transplant recipient population, so pregnancy in these immunocompromised patients is a concern. The incidence of unwanted pregnancy (a subset of unintended pregnancies) among female kidney transplant recipients is 48%, while the national incidence is 25%. The American Society of Transplantation (AST) has come to a consensus that gestations in organ transplant patients be considered high risk and be managed by both transplant physicians and high-risk pregnancy specialists. Pregnancies after organ transplantation have a high incidence of low birth weight (less than 2.5 kg).

The risks posed to the woman herself, her transplanted organ, and fetus underscore the importance of having health care providers counsel transplant patients on family planning, including return to fertility, contraceptive use, and when pregnancy can be safely considered. Specifically the fetus may be exposed to teratogenic immunosuppressive transplant medications and pregnancy increases the risk for rejection of the transplanted organ. Therefore it is important that women are thoroughly counseled regarding contraceptive effectiveness and safety. Health care providers have a large impact on the reproductive decisions that patients make. In a study done in transplant clinics across the nation, the majority of respondents based their decision on whether to become pregnant on the guidance of the individual transplant physician.

Transplant specialists may not be comfortably providing family planning services directly to patients. The Center for Disease Control and Prevention's United States Medical Eligibility Criteria for Contraceptive Use has specific guidance on the safety of each contraceptive for women undergoing solid organ transplants. However, this guidance is based on limited safety data. This study aims to add to the literature available on this patient population although we are not assessing safety. In addition, this study will identify improvement opportunities to the care provided to transplant patients within our own Health System.

This research study is a unique collaboration between the Departments of Pharmacy, Nephrology, and Reproductive Medicine.

Keywords

Contraception Contraception Behavior Contraceptive Usage Reproductive Health organ transplant

Eligibility

You can join if…

Open to females ages 18-50

  • Women 18-50 years old, solid organ transplant in the last 5 years, and fluent in English.

You CAN'T join if...

  • Not sexually active with men, history of hysterectomy, history of oophorectomy

Location

  • University of California, San Diego
    La Jolla California 92093 United States

Lead Scientist

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
Links
Organ Procurement and Transplantation Network
Centers for Disease Control (CDC) US Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
ID
NCT03979950
Study Type
Observational
Last Updated