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Piloting Use of Multi-Level Pregnancy Tests in Remote Abortion Services

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ClinicalTrials.gov Identifier: NCT03207880
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
safe2choose
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:

Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of gestation. This pilot project will assess whether MLPTs can enhance the quality of remote medical abortion services through enabling women to reliably ascertain their abortion outcomes at home sooner than would otherwise have been the case.

safe2choose provides remote medical abortion services through the Internet (information, counselling and access to abortion pills) in a growing number of countries worldwide. safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for home follow-up as part of its remote medical abortion services.

As safe2choose does not have a physical office, the location of the sponsor's office is listed in this entry as the study location. Women from the United States are NOT eligible to enroll.


Condition or disease Intervention/treatment Phase
Medical Abortion, Complete or Unspecified, Without Complication Device: Multi-level pregnancy test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Piloting an Innovation to Improve the Quality of Remote Abortion Services: Incorporating Use of Multi-Level Pregnancy Tests
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018

Arm Intervention/treatment
Experimental: MLPT
Multi-level pregnancy test
Device: Multi-level pregnancy test
Study participants will be instructed to perform a baseline MLPT immediately prior to administering the first dose of abortion medication and a second MLPT one week later to ascertain the follow-up hCG range. Any woman who obtains a stable or increasing hCG result, when comparing the baseline test result with the follow-up test result, will be instructed to contact safe2choose. Any woman who obtains a decrease in her hCG range, when comparing the baseline test result with the follow-up test result, will be informed that her abortion was a success and she is no longer pregnant.




Primary Outcome Measures :
  1. Proportion of women who successfully receive the MLPTs [ Time Frame: 1 week after mailing the MLPTs ]
  2. Proportion of women who use the MLPTs to determine their abortion outcome [ Time Frame: 2 weeks after receiving medical abortion package ]
  3. Proportion of women able to use MLPTs on their own without guidance or instruction from providers [ Time Frame: 2 weeks after receiving medical abortion package ]
  4. Proportion of women who take action based on the interpretation of their test results [ Time Frame: 2 weeks after receiving medical abortion package ]
  5. Proportion of women who are satisfied with using MLPTs [ Time Frame: 2 weeks after receiving medical abortion package ]

Secondary Outcome Measures :
  1. Proportion of all eligible safe2choose clients who elect to participate in the study [ Time Frame: 0 days after recruitment ]
  2. Proportion of women who find the MLPT instructions (written and video) to be helpful tools [ Time Frame: 2 weeks after enrollment ]


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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recipient of safe2choose medical abortion services
  • Able to read English or Spanish
  • ≤ 56 days LMP
  • Willing and able to read and sign consent form
  • Agree to comply with the study procedures, including completing the follow-up survey

Exclusion Criteria:

  • Does not meet inclusion 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): NCT03207880


Locations
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United States, New York
Gynuity Health Projects
New York, New York, United States, 10010
Sponsors and Collaborators
Gynuity Health Projects
safe2choose
Investigators
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Principal Investigator: Erica Chong, MPH Gynuity Health Projects
Principal Investigator: Jennifer Blum, MPH Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03207880     History of Changes
Other Study ID Numbers: 6011
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gynuity Health Projects:
pregnancy test