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Trial record 10 of 59 for:    abortion , gynuity

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

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ClinicalTrials.gov Identifier: NCT02570204
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Medical Abortion Behavioral: Self-assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Self-assessment of abortion outcome
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.
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.




Primary Outcome Measures :
  1. Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone [ Time Frame: One month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 56 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570204


Locations
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United States, Florida
Presidential Women's Center
West Palm Beach, Florida, United States, 33407
United States, Maryland
Carafem
Chevy Chase, Maryland, United States, 20815
United States, Pennsylvania
Philadelphia Women's Center
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Study Director: Elizabeth Raymond, MD, MPH Gynuity Health Projects

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02570204     History of Changes
Other Study ID Numbers: 1033
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017