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

Medical Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570204
• Other study ID #: 1033
• Status: Completed
• Phase: N/A
• First received: October 5, 2015
• Last updated: April 28, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 56 Years

Eligibility

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:

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Behavioral:
• Self-assessment
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.

Locations

Country	Name	City	State
United States	Carafem	Chevy Chase	Maryland
United States	Philadelphia Women's Center	Philadelphia	Pennsylvania
United States	Presidential Women's Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone		One month