Medical Abortion Self-Confirmation (MASC)

NCT ID: NCT03148587

Last Updated: 2019-06-07

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-31

Brief Summary

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This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.

Detailed Description

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Conditions

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Medical Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Multi-level pregnancy test (MLPT)

Patients randomized to multi-level pregnancy test (MLPT) arm will receive MLPTs to perform at home one and two weeks after taking mifepristone. They will be asked to interpret the results of the MLPT as it relates to their pregnancy termination status.

Group Type EXPERIMENTAL

Self-assessment: MLPT

Intervention Type BEHAVIORAL

Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.

Low sensitivity pregnancy test (LSPT)

Patients randomized to low sensitivity pregnancy test (LSPT) arm will receive LSPTs to perform at home at one and two weeks after taking mifepristone. They will be asked to interpret the results of the LSPT as it relates to their pregnancy termination status.

Group Type EXPERIMENTAL

Self-assessment: LSPT

Intervention Type BEHAVIORAL

Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.

Interventions

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Self-assessment: MLPT

Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.

Intervention Type BEHAVIORAL

Self-assessment: LSPT

Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Gestational age of less than or equal to 63 days
* English speaking
* 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
* 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

* Allergy to mifepristone and/or misoprostol
* Non-english speaking
* Inability to access internet
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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39816

Identifier Type: -

Identifier Source: org_study_id

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