Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
1 other identifier
interventional
343
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 1, 2017
April 1, 2017
1.3 years
October 5, 2015
April 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone
One month
Study Arms (1)
Self-assessment of abortion outcome
EXPERIMENTALPatients 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.
Interventions
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 Criteria
You may qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Presidential Women's Center
West Palm Beach, Florida, 33407, United States
Carafem
Chevy Chase, Maryland, 20815, United States
Philadelphia Women's Center
Philadelphia, Pennsylvania, 19106, United States
Related Publications (1)
Raymond EG, Tan YL, Grant M, Benavides E, Reis M, Sacks DN, Hannum C, Frapp S, Weaver MA. Self-assessment of medical abortion outcome using symptoms and home pregnancy testing. Contraception. 2018 Apr;97(4):324-328. doi: 10.1016/j.contraception.2017.12.004. Epub 2017 Dec 11.
PMID: 29242085DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elizabeth Raymond, MD, MPH
Gynuity Health Projects
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 1, 2017
Record last verified: 2017-04