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

NCT ID: NCT00994734

Last Updated: 2012-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Termination of Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

clinic administration of mifepristone

Group Type NO_INTERVENTION

No interventions assigned to this group

home administration of mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

home administration of mifepristone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mifepristone

home administration of mifepristone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Feminist Women's Health Center

Atlanta, Georgia, United States

Site Status

Institute for Family Health

New York, New York, United States

Site Status

Family Health Center, Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Municipal Clinical Hospital

Chisinau, , Moldova

Site Status

Kathmandu Medical College

Kathmandu, , Nepal

Site Status

Nepal Medical College Teaching Hospital

Kathmandu, , Nepal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Moldova Nepal

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25482435 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1.2.3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mail Order Mifepristone Study
NCT03913104 COMPLETED PHASE4
Mifepristone vs Misoprostol
NCT06502158 RECRUITING PHASE1