Medical Abortion Self-Confirmation (MASC)

NCT03148587 | Completed DMC

• 1 other identifier: 39816
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medical Abortion

Keywords

abortion; medical abortion; mifepristone; pregnancy test

Outcome Measures

Primary Outcomes (1)

• Correct interpretation of pregnancy test

  4 weeks after taking medication abortion medication, mifepristone

Study Arms (2)

Multi-level pregnancy test (MLPT)

EXPERIMENTAL

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

Low sensitivity pregnancy test (LSPT)

EXPERIMENTAL

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

Interventions

Self-assessment: MLPT BEHAVIORAL

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

Multi-level pregnancy test (MLPT)

Self-assessment: LSPT BEHAVIORAL

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

Low sensitivity pregnancy test (LSPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to mifepristone and/or misoprostol
• Non-english speaking
• Inability to access internet

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 11, 2017
• Study Start: May 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

US (1)