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

Not Applicable

Completed

• Conditions: Medical Abortion

• Registration Number: NCT02570204
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 343

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone	One month

Trial Locations

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