Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation
NCT ID: NCT01856985
Last Updated: 2013-10-11
Study Results
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.
COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2013-04-30
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Misoprostol at clinic
Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home.
Participants will be asked to return to the hospital 14 days later for a follow-up visit.
Misoprostol
Mifepristone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Misoprostol
Mifepristone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have an intrauterine pregnancy 78 days through 84 days' LMP
* Be willing and able to sign consent forms
* Agree to comply with study procedures and visit schedule
* Be living with 30 minutes from the hospital
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gynuity Health Projects
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Jennifer Blum, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Nguyen Thu Nhu Ngoc, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Research and Consultancy in Reproductive Health
Dina F Abbas
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hung Vuong Hospital
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1010
Identifier Type: -
Identifier Source: org_study_id