DiabetesNCT02219269
A Complex Contraception Registry
An observational study of Diabetes and Cardiovascular Disease, run by University of California, San Diego at 5 sites in United States.
Trial summary
The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes, Cardiovascular Disease, Epilepsy
- How many people
- 97 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2014to Jun 2015
- How long will I take part?
- 6 Months
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of women 18-45 years old and seeking contraception with the medical condition listed in inclusion criteria. Participants will be recruited from obstetrics and gynecology clinic at UCSD, UCLA, UCSF, UC Irvine and UC Davis. 250 participants will be enrolled. Approximately 50 cases will be recruited at each site.
Who may be able to join
- Ethnic Background: No limitation, will include minorities
- Sexually Active with men
- Diagnosis with at least one of the following conditions
- Diabetes and other endocrine disorders
- Cardiovascular Disease, such as Ischemic Heart Disease, Valvular disease, hypertension or pulmonary hypertension
- Epilepsy, Migraine, and other neurologic disorders
Show all 12Show fewer
- History of or current cancer
- History of or planning Bariatric Surgery
- History of or planning Solid Organ Transplant
- Systematic Lupus Erythematous and other rheumatologic conditions
- History of or current Venous Thrombosis Embolism
- Other Medical Conditions (such as Sickle Cell Disease or Cystic Fibrosis)
Who cannot join
- Pregnant at time of recruitment
- History of hysterectomy, bilateral oophorectomy, or sterilization procedure
- Unable to provide informed consent
- Attempting to become pregnant at time of recruitment
- Not sexually active with men
- No active telephone number or email for follow up
- Women who are pregnant will be excluded from this study. However, no pregnancy testing will be conducted; pregnancy status will be based on self-reporting by subjects.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
UCLA
Los Angeles, California, 90095
UC Irvine
Orange, California, 92868
UC Davis
Sacramento, California, 95817
UCSD
San Diego, California, 92103
UCSF
San Francisco, California, 94117
About this study
Official title: A Complex Contraception Registry - UC Family Planning Collaborative Study
The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.
Read the detailed description
Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.
The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.
Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.
- Conditions
- Diabetes, Cardiovascular Disease, Epilepsy, Migraine, Neurological Disorders, Cancer
- Keywords
- contraception, family planning, complex medical conditions
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Epilepsy, Migraine Disorders, Nervous System Diseases, Neoplasms, Lupus Erythematosus, Systemic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medically complex contraception users | Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive method continuation and satisfaction
Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.
Measured: 6 month
Secondary outcomes (4)
History of unintended pregnancy
Measured with questionnaire at baseline, 3 months, and 6 months
Measured: 6 months
Change in Medical Condition
Measured with questionnaire at 3 months and 6 months
Measured: 6 months
History of contraceptive methods used
Measured with questionnaire at baseline
Measured: 6 months
If Contraception is Accessed in post-partum or post-abortion setting
Measured with questionnaire at baseline, 3 months, and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Prospective
- Enrolment
- 97 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, San Francisco, University of California, Irvine, University of California, Davis
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Jody Steinauer, MD, Principal investigator, University of California, San FranciscoRadhika Rible, MD MS, Principal investigator, University of California, Los AngelesTabetha Harken, MD MPH, Principal investigator, UC IrvineCatherine Cansino, MD MPH, Principal investigator, UC DavisSheila Mody, MD MPH, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219269
- Sponsor's protocol ID
- 140166
- Status last verified
- Mar 2018
- First submitted
- 11 Aug 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Center for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81
Mody SK, Cansino C, Rible R, Farala JP, Steinauer J, Harken T; University of California Family Planning Collaborative. Contraceptive use among women with medical conditions: Factors that influence method choice. Semin Perinatol. 2020 Aug;44(5):151310. doi: 10.1016/j.semperi.2020.151310. Epub 2020 Aug 20.
PubMed 32888723
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Complex Contraception Registry - UC Family Planning Collaborative Study
- ClinicalTrials.gov ID
- NCT02219269
- Acronym / sponsor ID
- 140166
- Conditions
- Diabetes, Cardiovascular Disease, Epilepsy, Migraine, Neurological Disorders, Cancer
- Keywords
- contraception, family planning, complex medical conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, San Francisco, University of California, Irvine, University of California, Davis
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Aug 2014 (estimated)
- 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 investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.
Detailed description
Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.
The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.
Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medically complex contraception users | – | –Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of women 18-45 years old and seeking contraception with the medical condition listed in inclusion criteria. Participants will be recruited from obstetrics and gynecology clinic at UCSD, UCLA, UCSF, UC Irvine and UC Davis. 250 participants will be enrolled. Approximately 50 cases will be recruited at each site.
Key inclusion criteria (12 listed)
- Ethnic Background: No limitation, will include minorities
- Sexually Active with men
- Diagnosis with at least one of the following conditions
Key exclusion criteria (7 listed)
- Pregnant at time of recruitment
- History of hysterectomy, bilateral oophorectomy, or sterilization procedure
- Unable to provide informed consent
- Attempting to become pregnant at time of recruitment
- Not sexually active with men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contraceptive method continuation and satisfaction
Time frame: 6 month
Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.
4 secondary outcomes
History of unintended pregnancy
Time frame: 6 months
Change in Medical Condition
Time frame: 6 months
History of contraceptive methods used
Time frame: 6 months
If Contraception is Accessed in post-partum or post-abortion setting
Time frame: 6 months
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 14 Mar 2018.
- BackgroundCenter for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81
- Derived from this study: PubMed 32888723Mody SK, Cansino C, Rible R, Farala JP, Steinauer J, Harken T; University of California Family Planning Collaborative. Contraceptive use among women with medical conditions: Factors that influence method choice. Semin Perinatol. 2020 Aug;44(5):151310. doi: 10.1016/j.semperi.2020.151310. Epub 2020 Aug 20.
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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.
Jody Steinauer, MD principal investigator
University of California, San Francisco
Radhika Rible, MD MS principal investigator
University of California, Los Angeles
Tabetha Harken, MD MPH principal investigator
UC Irvine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Disease, run by University of California, San Diego at 5 sites 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 12 inclusion and 7 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contraceptive method continuation and satisfaction (time frame: 6 month). 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 NCT02219269, which also lists 2 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 14 Mar 2018.