NCT03207880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

June 30, 2017

Last Update Submit

September 26, 2018

Conditions

Medical Abortion, Complete or Unspecified, Without Complication

Keywords

pregnancy test

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

MLPT

EXPERIMENTAL

Multi-level pregnancy test

Device: Multi-level pregnancy test

Interventions

Multi-level pregnancy testDEVICE

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.

MLPT

Eligibility Criteria

AgeUp to 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynuity Health Projects

New York, New York, 10010, United States

Location

Study Officials

  • Erica Chong, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Jennifer Blum, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

November 1, 2017

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

US(1)