Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests

NCT ID: NCT02570204

Last Updated: 2017-05-01

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

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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

This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.

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.

Medical Abortion

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Self-assessment of abortion outcome

Patients enrolled in the study will self-assess the outcomes of their medical abortion with the aid of a multi-level pregnancy test (MLPT) which they will perform at home.

Group Type EXPERIMENTAL

Self-assessment

Intervention Type BEHAVIORAL

Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.

Interventions

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

Self-assessment

Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Gestational age of less than or equal to 63 days
* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
* Willing to use the MLPT at home
* 11-56 years old
* Willing and able to comply with study procedures
* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria

\-
Minimum Eligible Age

11 Years

Maximum Eligible Age

56 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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Raymond, MD, MPH

Role: STUDY_DIRECTOR

Gynuity Health Projects

Locations

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

Presidential Women's Center

West Palm Beach, Florida, United States

Site Status

Carafem

Chevy Chase, Maryland, United States

Site Status

Philadelphia Women's Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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

United States

References

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

Raymond EG, Tan YL, Grant M, Benavides E, Reis M, Sacks DN, Hannum C, Frapp S, Weaver MA. Self-assessment of medical abortion outcome using symptoms and home pregnancy testing. Contraception. 2018 Apr;97(4):324-328. doi: 10.1016/j.contraception.2017.12.004. Epub 2017 Dec 11.

Reference Type DERIVED
PMID: 29242085 (View on PubMed)

Other Identifiers

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

1033

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Pelvic Examination in Pregnancy
NCT01570413 COMPLETED NA