Medical AbortionMASCNCT03148587
Medical Abortion Self-Confirmation (MASC)
A study testing Self-assessment: MLPT and Self-assessment: LSPT in people with Medical Abortion, run by Stanford University at 1 site in United States.
Trial summary
This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Self-assessment: MLPT and Self-assessment: LSPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 May 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age of less than or equal to 63 days
- English speaking
- Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
- In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form
Who cannot join
- Allergy to mifepristone and/or misoprostol
- Non-english speaking
- Inability to access internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up
This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.
- Conditions
- Medical Abortion
- Being tested
- Self-assessment: MLPT, Self-assessment: LSPT
- Keywords
- abortion, medical abortion, mifepristone, pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assessment: MLPTBehavioural
Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.
Self-assessment: LSPTBehavioural
Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.
| Study group | Role | What they receive |
|---|---|---|
| Multi-level pregnancy test (MLPT) | Experimental | Patients randomized to multi-level pregnancy test (MLPT) arm will receive MLPTs to perform at home one and two weeks after taking mifepristone. They will be asked to interpret the results of the MLPT as it relates to their pregnancy termination status. Receives: Behavioral: Self-assessment: MLPT |
| Low sensitivity pregnancy test (LSPT) | Experimental | Patients randomized to low sensitivity pregnancy test (LSPT) arm will receive LSPTs to perform at home at one and two weeks after taking mifepristone. They will be asked to interpret the results of the LSPT as it relates to their pregnancy termination status. Receives: Behavioral: Self-assessment: LSPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct interpretation of pregnancy test
Measured: 4 weeks after taking medication abortion medication, mifepristone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 May 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148587
- Sponsor's protocol ID
- 39816
- Acronym
- MASC
- Status last verified
- Jun 2019
- First submitted
- 27 Apr 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up
- ClinicalTrials.gov ID
- NCT03148587
- Acronym / sponsor ID
- MASC / 39816
- Conditions
- Medical Abortion
- Keywords
- abortion, medical abortion, mifepristone, pregnancy test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 11 May 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.
This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-level pregnancy test (MLPT) | Experimental | Behavioral: Self-assessment: MLPTPatients randomized to multi-level pregnancy test (MLPT) arm will receive MLPTs to perform at home one and two weeks after taking mifepristone. They will be asked to interpret the results of the MLPT as it relates to their pregnancy termination status. |
| Low sensitivity pregnancy test (LSPT) | Experimental | Behavioral: Self-assessment: LSPTPatients randomized to low sensitivity pregnancy test (LSPT) arm will receive LSPTs to perform at home at one and two weeks after taking mifepristone. They will be asked to interpret the results of the LSPT as it relates to their pregnancy termination status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age of less than or equal to 63 days
- English speaking
- Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
- In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form
Key exclusion criteria (3 listed)
- Allergy to mifepristone and/or misoprostol
- Non-english speaking
- Inability to access internet
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 |
|---|---|---|
| Self-assessment: MLPTPatients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test. | Behavioural | Multi-level pregnancy test (MLPT) |
| Self-assessment: LSPTPatients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test. | Behavioural | Low sensitivity pregnancy test (LSPT) |
Primary outcome
Correct interpretation of pregnancy test
Time frame: 4 weeks after taking medication abortion medication, mifepristone
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 7 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-assessment: MLPT and Self-assessment: LSPT in people with Medical Abortion, run by Stanford University 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 4 inclusion and 3 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 7 Jun 2019. 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?
Correct interpretation of pregnancy test (time frame: 4 weeks after taking medication abortion medication, mifepristone). 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 7 Jun 2019.