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

Medical Abortion, Complete or Unspecified, Without Complication Clinical Trial

Official title:

Piloting an Innovation to Improve the Quality of Remote Abortion Services: Incorporating Use of Multi-Level Pregnancy Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207880
• Other study ID #: 6011
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: September 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Medical Abortion, Complete or Unspecified, Without Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Gynuity Health Projects	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	safe2choose

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who successfully receive the MLPTs		1 week after mailing the MLPTs
Primary	Proportion of women who use the MLPTs to determine their abortion outcome		2 weeks after receiving medical abortion package
Primary	Proportion of women able to use MLPTs on their own without guidance or instruction from providers		2 weeks after receiving medical abortion package
Primary	Proportion of women who take action based on the interpretation of their test results		2 weeks after receiving medical abortion package
Primary	Proportion of women who are satisfied with using MLPTs		2 weeks after receiving medical abortion package
Secondary	Proportion of all eligible safe2choose clients who elect to participate in the study		0 days after recruitment
Secondary	Proportion of women who find the MLPT instructions (written and video) to be helpful tools		2 weeks after enrollment