Medical Abortion Self-Confirmation (MASC)

Stanford University

Status: Completed

Conditions: Medical Abortion

Treatments: Behavioral: Self-assessment: MLPT; Behavioral: Self-assessment: LSPT

Study type: Interventional

Funder types: Other

Identifiers

NCT03148587

39816

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Multi-level pregnancy test (MLPT)

Experimental group

Description:

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.

Treatment:

Behavioral: Self-assessment: MLPT

Low sensitivity pregnancy test (LSPT)

Experimental group

Description:

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.

Treatment:

Behavioral: Self-assessment: LSPT