Clinical trial NCT03207880: Piloting Use of Multi-Level Pregnancy Tests in Remote Abortion Services
Official title: Piloting an Innovation to Improve the Quality of Remote Abortion Services: Incorporating Use of Multi-Level Pregnancy Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion, Complete or Unspecified, Without Complication
Keywords: pregnancy test
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: safe2choose
First posted: 2017-07-05
Enrollment: 165
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Proportion of women who successfully receive the MLPTs
timeFrame: 1 week after mailing the MLPTs
measure: Proportion of women who use the MLPTs to determine their abortion outcome
timeFrame: 2 weeks after receiving medical abortion package
measure: Proportion of women able to use MLPTs on their own without guidance or instruction from providers
timeFrame: 2 weeks after receiving medical abortion package
measure: Proportion of women who take action based on the interpretation of their test results
timeFrame: 2 weeks after receiving medical abortion package
measure: Proportion of women who are satisfied with using MLPTs
timeFrame: 2 weeks after receiving medical abortion package
Secondary outcomes:
measure: Proportion of all eligible safe2choose clients who elect to participate in the study
timeFrame: 0 days after recruitment
measure: Proportion of women who find the MLPT instructions (written and video) to be helpful tools
timeFrame: 2 weeks after enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: Gynuity Health Projects
state: New York
Study officials:
affiliation: Gynuity Health Projects
name: Erica Chong, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: