Clinical Trials Directory

Trials / Completed

CompletedNCT03979950

Contraception for Solid Organ Transplant Patients: Utilizing Social Media

Status
Completed
Phase
Study type
Observational
Enrollment
52 (actual)
Sponsor
University of California, San Diego · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSurveySolid Organ Transplant patients will be recruited via social media. Co-investigators will reach out to the administrators of various social media networks to share information regarding the study with their networks on our behalf. Potential participants who are interested in participating, can then follow the link to the online survey tool, which includes the participant demographic information (age, ethnicity and highest level of education) and questionnaire. The questionnaire is 30 questions long and takes approximately 15 minutes to complete. This questionnaire will be a single, cross-sectional survey. No personal information will be documented on the questionnaire. All responses will be anonymous. Participants will be recruited for 6 months.

Timeline

Start date
2018-01-18
Primary completion
2020-09-01
Completion
2020-12-01
First posted
2019-06-10
Last updated
2023-03-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03979950. Inclusion in this directory is not an endorsement.