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Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
This study is currently recruiting participants.
Verified May 2017 by Gynuity Health Projects
Sponsor:
Gynuity Health Projects
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT02513043
First received: July 24, 2015
Last updated: May 10, 2017
Last verified: May 2017
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 24, 2015 | ||||||
| Last Updated Date | May 10, 2017 | ||||||
| Start Date ICMJE | March 22, 2016 | ||||||
| Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] adverse events |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | Complete list of historical versions of study NCT02513043 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine | ||||||
| Official Title ICMJE | Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine | ||||||
| Brief Summary | This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion. | ||||||
| Detailed Description | The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion. | ||||||
| Study Type ICMJE | Observational | ||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Women seeking abortion | ||||||
| Condition ICMJE | Pregnancy | ||||||
| Intervention ICMJE | Drug: medical abortion
medical abortion |
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 1000 | ||||||
| Estimated Completion Date | June 2018 | ||||||
| Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 11 Years to 50 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts ICMJE | |||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02513043 | ||||||
| Other Study ID Numbers ICMJE | 1031 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Gynuity Health Projects | ||||||
| Study Sponsor ICMJE | Gynuity Health Projects | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Gynuity Health Projects | ||||||
| Verification Date | May 2017 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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