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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same-day-start | Active Comparator | 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 |
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| Delay-for-diagnosis | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same-day-start | Other | 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 |
| 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 |
| 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 |
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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:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 6176161600 | research@pplm.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPLM | Recruiting | Boston | Massachusetts | 02215 | United States |
We do not plan to share individual participant data with any other researchers.
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randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
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| Delay-for-diagnosis | Other | 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 |
|
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 |