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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02570204
Enrollment
343
Registered
2015-10-07
Start date
2015-09-30
Completion date
2016-12-31
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Abortion

Brief summary

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.

Interventions

BEHAVIORALSelf-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.

Sponsors

Gynuity Health Projects
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
11 Years to 56 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frame
Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristoneOne month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026