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
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|
|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|
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.
- Proportion of women who successfully receive the MLPTs [ Time Frame: 1 week after mailing the MLPTs ]
- Proportion of women who use the MLPTs to determine their abortion outcome [ Time Frame: 2 weeks after receiving medical abortion package ]
- 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 ]
- Proportion of women who take action based on the interpretation of their test results [ Time Frame: 2 weeks after receiving medical abortion package ]
- Proportion of women who are satisfied with using MLPTs [ Time Frame: 2 weeks after receiving medical abortion package ]
- Proportion of all eligible safe2choose clients who elect to participate in the study [ Time Frame: 0 days after recruitment ]
- Proportion of women who find the MLPT instructions (written and video) to be helpful tools [ Time Frame: 2 weeks after enrollment ]
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
|United States, New York|
|Gynuity Health Projects|
|New York, New York, United States, 10010|
|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|