Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Correct interpretation of pregnancy test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •Allergy to mifepristone and/or misoprostol
- •Non-english speaking
- •Inability to access internet
Arms & Interventions
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.
Intervention: Self-assessment: MLPT (Behavioral)
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.
Intervention: Self-assessment: LSPT (Behavioral)
Outcomes
Primary Outcomes
Correct interpretation of pregnancy test
Time Frame: 4 weeks after taking medication abortion medication, mifepristone
Secondary Outcomes
No secondary outcomes reported