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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
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Purpose
This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.
| Condition | Intervention |
|---|---|
| Pregnancy | Drug: medical abortion |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine |
Further study details as provided by Gynuity Health Projects:
Primary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]adverse events
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 22, 2016 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: medical abortion
medical abortion
The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.
Eligibility| Ages Eligible for Study: | 11 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Women seeking abortion
Criteria
Inclusion Criteria:
- desires abortion
Exclusion Criteria:
- medically ineligible for procedure
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02513043
Please refer to this study by its ClinicalTrials.gov identifier: NCT02513043
Locations
| United States, Hawaii | |
| The University of Hawaii Women's Options Centers | Recruiting |
| Honolulu, Hawaii, United States, 96826 | |
| Contact: Mary Tschann, MPH 808-203-6561 | |
| Principal Investigator: Bliss Kaneshiro, MD, MPH | |
| United States, Maine | |
| Maine Family Planning | Not yet recruiting |
| Augusta, Maine, United States | |
| Contact: Shannon Mackey 207-248-3924 | |
| Principal Investigator: Leah Coplon, MPH, RN | |
| United States, New York | |
| Choices Women's Medical Center | Active, not recruiting |
| Jamaica, New York, United States, 11435 | |
| United States, Oregon | |
| Oregon Health and Sciences University Women's Health Research Unit | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Ariela Schyner 503-494-3959 | |
| Principal Investigator: Maureen Baldwin, MD | |
Sponsors and Collaborators
Gynuity Health Projects
Investigators
| Principal Investigator: | Erica Chong, MPH | Gynuity Health Projects |
| Principal Investigator: | Elizabeth Raymond, MD, MPH | Gynuity Health Projects |
More Information
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT02513043 History of Changes |
| Other Study ID Numbers: |
1031 |
| Study First Received: | July 24, 2015 |
| Last Updated: | May 10, 2017 |
ClinicalTrials.gov processed this record on July 14, 2017