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

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.

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Key information

Conditions

Medical Abortion

Age range

11 year–56 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Presidential Women's Center, West Palm Beach, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-assessment

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.

Primary outcomes

Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone

Time frame: One month

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 7, 2015
Registry last updated: May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed