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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03207880
Enrollment
165
Registered
2017-07-05
Start date
2017-11-01
Completion date
2018-08-10
Last updated
2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Abortion, Complete or Unspecified, Without Complication

Keywords

pregnancy test

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.

Interventions

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.

Sponsors

safe2choose
CollaboratorUNKNOWN
Gynuity Health Projects
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Proportion of women who use the MLPTs to determine their abortion outcome2 weeks after receiving medical abortion package
Proportion of women who take action based on the interpretation of their test results2 weeks after receiving medical abortion package
Proportion of women who are satisfied with using MLPTs2 weeks after receiving medical abortion package
Proportion of women who successfully receive the MLPTs1 week after mailing the MLPTs
Proportion of women able to use MLPTs on their own without guidance or instruction from providers2 weeks after receiving medical abortion package

Secondary

MeasureTime frame
Proportion of women who find the MLPT instructions (written and video) to be helpful tools2 weeks after enrollment
Proportion of all eligible safe2choose clients who elect to participate in the study0 days after recruitment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026