Medication Abortion for Pregnancy of Unknown Location

Study Overview
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Brief Summary
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The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.

Official Title
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Medication Abortion for Pregnancy of Unknown Location

Conditions
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Pregnancy Related

Intervention / Treatment
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* Other: Same-day-start
* Other: Delay-for-diagnosis


Participation Criteria
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Eligibility Criteria
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Patients with an undesired pregnancy of less than or equal to 42 days gestation based on last menstrual period (LMP) who present to Planned Parenthood League of Massachusetts (PPLM)'s Greater Boston Health Center seeking medication abortion will be considered for study participation. Inclusion criteria: Positive urine or serum hCG test No evidence of gestational sac on transvaginal ultrasound Desire for medication abortion as method of pregnancy termination Exclusion criteria: Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Same-day-start<br>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 | Other: Same-day-start<br>* 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<br>|
| Active Comparator: Delay-for-diagnosis<br>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 | Other: Delay-for-diagnosis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to completed abortion | Time to completed abortion as defined by the number of days between initial ultrasound diagnosis of PUL to the diagnostic test that confirms complete abortion | through study completion, an average of two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete expulsion of pregnancy without surgical intervention | Efficacy of medical abortion, defined as number of participants with complete expulsion of pregnancy without surgical intervention | 14 days after initiation of medical abortion | 
| Time to diagnosis of pregnancy outcome | Number of days between initial ultrasound diagnosis of pregnancy of unknown location and diagnosis of pregnancy outcome, with options including intrauterine pregnancy, ectopic pregnancy, or early pregnancy loss | Within 2 weeks of identification of pregnancy of unknown location on ultrasound | 
| Rate of ectopic pregnancy | Rate of ectopic pregnancy among entire study population | Within 2 weeks of identification of pregnancy of unknown location on ultrasound | 
| Percent of participants who complete follow-up and confirm complete abortion | Percent of participants who adhered to recommended follow-up plan and confirmed a complete abortion through ultrasound or hCG | Within 1 month of identification of pregnancy of unknown location on ultrasound |