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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UNKNOWN
NA
57 participants
INTERVENTIONAL
2019-07-22
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Same-day-start
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing
Same-day-start
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing
Delay-for-diagnosis
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion
Delay-for-diagnosis
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion
Interventions
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Same-day-start
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing
Delay-for-diagnosis
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion
Eligibility Criteria
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Inclusion Criteria
* No evidence of gestational sac on transvaginal ultrasound
* Desire for medication abortion as method of pregnancy termination
Exclusion Criteria
* Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
* High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
* Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
* LMP \> 42 days or unknown LMP
* Age less than 18 years
* Prior participation in this study
* Anticipated inability to present for scheduled follow-up visits
18 Years
FEMALE
Yes
Sponsors
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Planned Parenthood League of Massachusetts
OTHER
Responsible Party
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Locations
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PPLM
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019P000848
Identifier Type: -
Identifier Source: org_study_id
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