Telehealth for Contraception

Recruiting in Portland (>99 mi)

Overseen By Women's Health Research Unit Department of Ob/Gyn

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Pregnancy, Ectopic pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate advanced provision of an anti-progestin with a prostaglandin for future use (in the next 12 months) in individuals at risk for pregnancy but not desiring a pregnancy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants or long-term corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Advanced Provision of Care, Telehealth Visit for contraception?

Research shows that telehealth can improve access to contraception, as seen in studies where patients used online platforms to request birth control and reported satisfaction with telehealth services for contraceptive care. ^{1 2 3 4 5}

Is telehealth for contraception generally safe for humans?

The research articles provided do not contain specific safety data about telehealth for contraception or related terms like Advanced Provision of Care or Telehealth Visit. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How is the treatment 'Advanced Provision of Care' for contraception unique?

The 'Advanced Provision of Care' treatment is unique because it uses telehealth to provide contraception, making it more accessible for people in rural areas or those who face barriers to in-person visits. This approach can help fill gaps in access to contraceptive services by allowing patients to receive care remotely. ^{2 5 11 12 13}

Eligibility Criteria

This trial is for individuals aged 18-40 who are at risk of unintended pregnancy, not currently pregnant, and would choose to end a pregnancy within the next year. They must be sexually active without permanent contraception or LARC, have regular menstrual cycles, and plan to stay in Oregon or Washington for one year.

Inclusion Criteria

Self-reported a history of regular menses (>24 and <38 days) in the past 3 years (other than during pregnancy)

Anatomically capable of pregnancy

I would choose to end a pregnancy within the next year and prefer not to have an in-office procedure.

Exclusion Criteria

I would not consider terminating a pregnancy if I became pregnant in the next year.

I don't have bleeding disorders, long-term steroid use, porphyria, or allergies to specific medications.

Currently pregnant or desiring pregnancy in the next year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telehealth Visit

Participants receive counseling via telemedicine and advanced provision of medications

1 visit

1 visit (virtual)

Follow-up

Participants are monitored for satisfaction and confidence in medication use through follow-up surveys

12 months

Treatment Details

Interventions

• Advanced Provision of Care
• Telehealth Visit

Trial Overview The study tests advanced provision of anti-progestin with prostaglandin via telehealth visits for those who may need it within the next year but do not wish to become pregnant now.

Participant Groups

Group I: Telehealth Visit Experimental Treatment 1 Intervention

telemedicine visit and follow-up surveys

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Findings from Research

A survey of 81 fertility patients revealed that 81.4% were satisfied with telehealth for fertility care, highlighting its usefulness, ease of use, and effectiveness.

Despite high satisfaction with telehealth, 60.5% of patients preferred in-person visits for their initial consultation, suggesting that while telehealth is effective, many still value face-to-face interactions for starting their fertility journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives of telehealth for fertility care: a national survey. Lersten, I., Fought, A., Yannetsos, C., et al.[2023]

A comparison of adverse event reports (AERs) for mifepristone abortions from 2009 to 2010 revealed significant discrepancies, with Cleland et al. documenting 1530 cases while the FDA's FAERS reported only 664 total AERs.

The findings suggest that the FAERS system may be inadequate for accurately assessing the safety of mifepristone abortions, as it reported only a fraction of ongoing pregnancies (95) compared to Cleland's documentation (1158).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act. Cirucci, CA., Aultman, KA., Harrison, DJ.[2022]

The use of the MedWatcher app, combined with outreach to a Facebook patient community, significantly reduced the time to submit adverse event reports for the Essure device, averaging only 11.4 minutes compared to the typical 40 minutes for traditional methods.

Patients reported a high number of serious adverse events (77.6% of submissions), including hospitalization and permanent damage, and the reports submitted via the app were found to be 15 times more frequent than those through traditional reporting channels, indicating improved engagement and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. Bahk, CY., Goshgarian, M., Donahue, K., et al.[2019]

The SmartVax SMS-based system effectively monitored adverse events following immunization (AEFI) in a diverse population of 276 participants in Switzerland, achieving a high response rate of 90.3%.

The study found that 29.8% of immunization visits reported at least one AEFI, with the Shingrix® vaccine showing the highest rate of reactions, indicating that SmartVax can be a reliable tool for real-time vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. Guedel, DS., Peters, IJ., Banderet, F., et al.[2021]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Response to requests for contraception in one direct-to-consumer telemedicine service. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Who Accesses Birth Control Online? An Analysis of Requests for Contraception Submitted to an Online Prescribing Platform in the United States. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patient perspectives of telehealth for fertility care: a national survey. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Client experiences with telehealth using LINE for consultation and assessment of adverse effects of contraceptive implants during the COVID-19 pandemic in Thailand. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Telehealth contraceptive care in 2018: A quality improvement study of barriers to access and patient satisfaction. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in Norplant users reported to the Food and Drug Administration's MedWatch Spontaneous Reporting System. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

"The Closer, the Better:" The Role of Telehealth in Increasing Contraceptive Access Among Women in Rural South Carolina. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Contraceptive care service provision via telehealth early in the COVID-19 pandemic at rural and urban federally qualified health centers in 2 southeastern states. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

An exploratory study comparing the quality of contraceptive counseling provided via telemedicine versus in-person visits. [2022]