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临床试验/NCT03979950
NCT03979950已完成不适用

Contraception for Solid Organ Transplant Patients: Utilizing Social Media

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Number of participants counseled on contraception by provider

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

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

结局指标

主要结局

Number of participants counseled on contraception by provider

时间窗: Three years

The survey questionnaire asked multiple-choice questions about (1) which, if any, provider(s) counseled them on contraception and (2) from which provider(s), if any, would they prefer to receive contraceptive counseling.

Level of knowledge among solid organ transplant patients about contraceptive methods

时间窗: Three years

The survey questionnaire asks multiple-choice questions about (1) available contraceptive methods, (2) the safety profile of methods for women with transplant histories, and (3) the teratogenic risks of post-transplant medications.

Quantity of contraceptive counseling for solid organ transplant patients

时间窗: Three years

The survey questionnaire asks multiple-choice questions about (1) whether patients received counseling about contraception and (2) if they want more counseling on contraception.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Mody

Assistant Professor

University of California, San Diego

研究点 (1)

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