ContraceptionNCT03979950
Contraception for Solid Organ Transplant Patients: Utilizing Social Media
An observational study of Contraception and Contraception Behavior, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Contraception Behavior, Contraceptive Usage
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women 18-50 years, solid organ transplant in the last 5 years, and fluent in English.
Who may be able to join
- Women 18-50 years old, solid organ transplant in the last 5 years, and fluent in English.
Who cannot join
- Not sexually active with men, history of hysterectomy, history of oophorectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
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.
Read the 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.
- Being tested
- Survey
- Keywords
- organ transplant
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of knowledge among solid organ transplant patients about contraceptive methods
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.
Measured: Three years
Quantity of contraceptive counseling for solid organ transplant patients
The survey questionnaire asks multiple-choice questions about (1) whether patients received counseling about contraception and (2) if they want more counseling on contraception.
Measured: Three years
Number of participants counseled on contraception by provider
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start18 Jan 2018
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila Mody, MD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979950
- Sponsor's protocol ID
- 170592X
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Organ Procurement and Transplantation Network. Organ Procurement and Transplantation Network, HRSA, DHHS 9 A.D. November 10. Available from http://optn.transplant.hrsa.gov/.
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.
PubMed 15251344McKay 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.
PubMed 15943616McKay 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.
PubMed 16789701Centers 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.
PubMed 20559203Guazzelli 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.
PubMed 18791448
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraception for Solid Organ Transplant Patients: Utilizing Social Media
- ClinicalTrials.gov ID
- NCT03979950
- Acronym / sponsor ID
- 170592X
- Keywords
- organ transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women 18-50 years, solid organ transplant in the last 5 years, and fluent in English.
Key inclusion criteria (1 listed)
- Women 18-50 years old, solid organ transplant in the last 5 years, and fluent in English.
Key exclusion criteria (1 listed)
- Not sexually active with men, history of hysterectomy, history of oophorectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySolid 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. | Behavioural | – |
Primary outcome
Level of knowledge among solid organ transplant patients about contraceptive methods
Time frame: 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
Time frame: 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.
Number of participants counseled on contraception by provider
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- BackgroundOrgan Procurement and Transplantation Network. Organ Procurement and Transplantation Network, HRSA, DHHS 9 A.D. November 10. Available from http://optn.transplant.hrsa.gov/.
- Background: PubMed 15251344Lessan-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.
- Background: PubMed 15943616McKay 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.
- Background: PubMed 16789701McKay 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.
- Background: PubMed 20559203Centers 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.
- Background: PubMed 18791448Guazzelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila Mody, MD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Contraception Behavior, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of knowledge among solid organ transplant patients about contraceptive methods (time frame: Three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979950, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.