Contraception for Solid Organ Transplant Patients: Utilizing Social Media

NCT ID: NCT03979950

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2020-12-01

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.

Conditions

Contraception; Contraception Behavior; Contraceptive Usage; Reproductive Health

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Survey

Solid 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheila Mody

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila Mody, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

Organ Procurement and Transplantation Network. Organ Procurement and Transplantation Network, HRSA, DHHS 9 A.D. November 10. Available from http://optn.transplant.hrsa.gov/.

Reference Type: BACKGROUND

Lessan-Pezeshki M, Ghazizadeh S, Khatami MR, Mahdavi M, Razeghi E, Seifi S, Ahmadi F, Maziar S. Fertility and contraceptive issues after kidney transplantation in women. Transplant Proc. 2004 Jun;36(5):1405-6. doi: 10.1016/j.transproceed.2004.04.090.

Reference Type: BACKGROUND

PMID: 15251344 (View on PubMed)

McKay DB, Josephson MA, Armenti VT, August P, Coscia LA, Davis CL, Davison JM, Easterling T, Friedman JE, Hou S, Karlix J, Lake KD, Lindheimer M, Matas AJ, Moritz MJ, Riely CA, Ross LF, Scott JR, Wagoner LE, Wrenshall L, Adams PL, Bumgardner GL, Fine RN, Goral S, Krams SM, Martinez OM, Tolkoff-Rubin N, Pavlakis M, Scantlebury V; Women's Health Committee of the American Society of Transplantation. Reproduction and transplantation: report on the AST Consensus Conference on Reproductive Issues and Transplantation. Am J Transplant. 2005 Jul;5(7):1592-9. doi: 10.1111/j.1600-6143.2005.00969.x.

Reference Type: BACKGROUND

PMID: 15943616 (View on PubMed)

McKay DB, Adams PL, Bumgardner GL, Davis CL, Fine RN, Krams SM, Martinez OM, Murphy B, Pavlakis M, Tolkoff-Rubin N, Sherman MS, Josephson MA. Reproduction and pregnancy in transplant recipients: current practices. Prog Transplant. 2006 Jun;16(2):127-32. doi: 10.1177/152692480601600206.

Reference Type: BACKGROUND

PMID: 16789701 (View on PubMed)

Centers for Disease Control and Prevention (CDC). U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep. 2010 Jun 18;59(RR-4):1-86.

Reference Type: BACKGROUND

PMID: 20559203 (View on PubMed)

Guazzelli CA, Torloni MR, Sanches TF, Barbieri M, Pestana JO. Contraceptive counseling and use among 197 female kidney transplant recipients. Transplantation. 2008 Sep 15;86(5):669-72. doi: 10.1097/TP.0b013e3181817e7d.

Reference Type: BACKGROUND

PMID: 18791448 (View on PubMed)

Related Links

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a1.htm?s_cid=rr5904a1_e.

Centers for Disease Control (CDC) US Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010

Other Identifiers

170592X

Identifier Type: -

Identifier Source: org_study_id