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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-08-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Medical Abortion, Complete or Unspecified, Without Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MLPT

Multi-level pregnancy test

Group Type EXPERIMENTAL

Multi-level pregnancy test

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes