Viewing Study NCT01811056


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Study NCT ID: NCT01811056
Status: COMPLETED
Last Update Posted: 2015-08-13
First Post: 2013-03-11
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Sponsor: Gynuity Health Projects
Organization:

Study Overview

Official Title: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Status: COMPLETED
Status Verified Date: 2015-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.
Detailed Description: This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: