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

Gynuity Health Projects343 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

343

Conditions

Medical Abortion

Interventions

Self-assessmentBEHAVIORAL

Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.

Eligibility

Sex: FEMALEMin age: 11 YearsMax age: 56 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (3)

Presidential Women's Center

West Palm Beach, Florida, United States

Carafem

Chevy Chase, Maryland, United States

Philadelphia Women's Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone

Time frame: One month

Data from ClinicalTrials.gov

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