Choice of Modality of Follow up for Medication Abortion
NCT ID: NCT04056637
Last Updated: 2020-05-28
Study Results
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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TERMINATED
NA
26 participants
INTERVENTIONAL
2019-09-09
2020-03-31
Brief Summary
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This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group 1: Standard of Care
Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider.
No interventions assigned to this group
Group 2: Flexible Follow-Up
Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy
Choice of follow-up option
Participant will be given the opportunity to choose from 3 follow-up options.
Multi-level pregnancy test
The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
Interventions
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Choice of follow-up option
Participant will be given the opportunity to choose from 3 follow-up options.
Multi-level pregnancy test
The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In general good health
* English or Spanish speaking competency
* Willing and able to sign consent forms
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Gynuity Health Projects
OTHER
Stanford University
OTHER
Responsible Party
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Locations
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Stanford Health Care
Stanford, California, United States
Countries
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Other Identifiers
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52312
Identifier Type: -
Identifier Source: org_study_id
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