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

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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion, Complete or Unspecified, Without Complication
• Intervention / Treatment: Device: Multi-level pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Gynuity Health Projects

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: safe2choose
• Investigators: Principal Investigator: Erica Chong, MPH, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy test
• Other Study ID Numbers: 6011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No