Medical Abortion, Complete or Unspecified, Without ComplicationNCT03207880
Piloting Use of Multi-Level Pregnancy Tests in Remote Abortion Services
A study testing Multi-level pregnancy test in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Gynuity Health Projects at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion, Complete or Unspecified, Without Complication
- What is being tested?
- Multi-level pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 10 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Multi-level pregnancy test
- Keywords
- pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MLPT | Experimental | Multi-level pregnancy test Receives: Device: Multi-level pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who successfully receive the MLPTs
Measured: 1 week after mailing the MLPTs
Proportion of women who use the MLPTs to determine their abortion outcome
Measured: 2 weeks after receiving medical abortion package
Proportion of women able to use MLPTs on their own without guidance or instruction from providers
Measured: 2 weeks after receiving medical abortion package
Proportion of women who take action based on the interpretation of their test results
Measured: 2 weeks after receiving medical abortion package
Proportion of women who are satisfied with using MLPTs
Measured: 2 weeks after receiving medical abortion package
Secondary outcomes (2)
Proportion of all eligible safe2choose clients who elect to participate in the study
Measured: 0 days after recruitment
Proportion of women who find the MLPT instructions (written and video) to be helpful tools
Measured: 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Nov 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Abortion, Complete or Unspecified, Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- safe2choose
- Responsible party
- Sponsor
- Investigators
- Erica Chong, MPH, Principal investigator, Gynuity Health ProjectsJennifer Blum, MPH, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207880
- Sponsor's protocol ID
- 6011
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2017
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Innovation to Improve the Quality of Remote Abortion Services: Incorporating Use of Multi-Level Pregnancy Tests
- ClinicalTrials.gov ID
- NCT03207880
- Acronym / sponsor ID
- 6011
- Keywords
- pregnancy test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- safe2choose
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MLPT | Experimental | Device: Multi-level pregnancy testMulti-level pregnancy test |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-level pregnancy testStudy 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. | Device | MLPT |
Primary outcome
Proportion of women who successfully receive the MLPTs
Time frame: 1 week after mailing the MLPTs
Proportion of women who use the MLPTs to determine their abortion outcome
Time frame: 2 weeks after receiving medical abortion package
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
Proportion of women who take action based on the interpretation of their test results
Time frame: 2 weeks after receiving medical abortion package
Proportion of women who are satisfied with using MLPTs
Time frame: 2 weeks after receiving medical abortion package
2 secondary outcomes
Proportion of all eligible safe2choose clients who elect to participate in the study
Time frame: 0 days after recruitment
Proportion of women who find the MLPT instructions (written and video) to be helpful tools
Time frame: 2 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Chong, MPH principal investigator
Gynuity Health Projects
Jennifer Blum, MPH principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level pregnancy test in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Gynuity Health Projects at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who successfully receive the MLPTs (time frame: 1 week after mailing the MLPTs). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.