Medication Abortion for Pregnancy of Unknown Location

Not Applicable

• Conditions: Pregnancy Related
• Interventions: Other: Same-day-start; Other: Delay-for-diagnosis

• Registration Number: NCT04026789
• Lead Sponsor: Planned Parenthood League of Massachusetts

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-07-22
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Same-day-start	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	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

Primary Outcome Measures

Name	Time	Method
Time to completed abortion	through study completion, an average of two weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PPLM; 🇺🇸 Boston, Massachusetts, United States