Uptake and Acceptability of Home-use of Mifepristone for... | NCT00994734

Studies
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

NCT00994734

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Apr 17, 2012Estimated

Enrollment

615Actual

Phase

Not Applicable

Conditions

Termination of Pregnancy

Interventions

Mifepristone

Countries

United States
Moldova
Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Oct 9, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Description Module

Brief Summary

The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

615Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clinic administration of mifepristone	No Intervention
home administration of mifepristone	Experimental		Drug: Mifepristone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mifepristone	Drug	home administration of mifepristone	home administration of mifepristone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of women who select home-use of mifepristone		1-2 weeks
Satisfaction with Method		1-2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Reproductive age women seeking abortion services.
Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken.
Participants must be eligible for medical abortion according to clinician and clinic standards.
In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Feminist Women's Health Center		Atlanta	Georgia		United States
Institute for Family Health

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25482435	Derived	Conkling K, Karki C, Tuladhar H, Bracken H, Winikoff B. A prospective open-label study of home use of mifepristone for medical abortion in Nepal. Int J Gynaecol Obstet. 2015 Mar;128(3):220-3. doi: 10.1016/j.ijgo.2014.09.022. Epub 2014 Nov 27.

Type	Date	Date Unknown
Release	Mar 18, 2013
Reset	May 15, 2013

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds