Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests

Gynuity Health Projects

Status: Completed

Conditions: Medical Abortion

Treatments: Behavioral: Self-assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02570204

1033

Details and patient eligibility

About

This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.

Enrollment: 343 patients

Sex: Female

Ages: 11 to 56 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age of less than or equal to 63 days
• 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
• Willing to use the MLPT at home
• 11-56 years old
• Willing and able to comply with study procedures
• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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343 participants in 1 patient group

Self-assessment of abortion outcome

Experimental group

Description:

Patients enrolled in the study will self-assess the outcomes of their medical abortion with the aid of a multi-level pregnancy test (MLPT) which they will perform at home.

Treatment:

Behavioral: Self-assessment