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CompletedNCT03148587MASCUpdated Jun 7, 2019

Medical Abortion Self-Confirmation (MASC)

An interventional study of Self-assessment: MLPT and Self-assessment: LSPT in Medical Abortion, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Medical Abortion

Keywords

  • abortion
  • medical abortion
  • mifepristone
  • pregnancy test
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Allergy to mifepristone and/or misoprostol
  • Non-english speaking
  • Inability to access internet
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralSelf-assessment: MLPT

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

  • BehavioralSelf-assessment: LSPT

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

06

What researchers measure

Primary outcomes

  1. Correct interpretation of pregnancy test

    Time frame: 4 weeks after taking medication abortion medication, mifepristone

07

Study locations

1 site
  • Stanford Health Care
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03148587
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
May 11, 2017
Start date
May 1, 2017
Primary completion
May 31, 2018
Completion
May 31, 2018
Last update
Jun 7, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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