Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 10:08 PM
Study NCT ID:
NCT03979950
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contraception for Solid Organ Transplant Patients: Utilizing Social Media
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Contraception for Solid Organ Transplant Patients: Utilizing Social Media
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: