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OpenTrials
Completed

NCT Number: NCT03207880

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

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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Key information

Conditions

Medical Abortion, Complete or Unspecified, Without Complication

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynuity Health Projects

New York, 10010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-level pregnancy test

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.

Primary outcomes

  1. Proportion of women who successfully receive the MLPTs

    Time frame: 1 week after mailing the MLPTs

  2. Proportion of women who use the MLPTs to determine their abortion outcome

    Time frame: 2 weeks after receiving medical abortion package

  3. Proportion of women able to use MLPTs on their own without guidance or instruction from providers

    Time frame: 2 weeks after receiving medical abortion package

  4. Proportion of women who take action based on the interpretation of their test results

    Time frame: 2 weeks after receiving medical abortion package

  5. Proportion of women who are satisfied with using MLPTs

    Time frame: 2 weeks after receiving medical abortion package

Secondary outcomes

  1. Proportion of all eligible safe2choose clients who elect to participate in the study

    Time frame: 0 days after recruitment

  2. Proportion of women who find the MLPT instructions (written and video) to be helpful tools

    Time frame: 2 weeks after enrollment

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • safe2choose

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2017
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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