Medical Abortion Self-Confirmation (MASC) (MASC)

June 5, 2019 updated by: Stanford University

Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Self-assessment: MLPT
Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.
Experimental: 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.
Behavioral: Self-assessment: LSPT
Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correct interpretation of pregnancy test
Time Frame: 4 weeks after taking medication abortion medication, mifepristone
4 weeks after taking medication abortion medication, mifepristone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 39816

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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