Medication Abortion for Pregnancy of Unknown Location (MAPUL)

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Same-day-start; Other: Delay-for-diagnosis

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • PPLM
      • Contact: Research Manager; Phone Number: 617-616-1600; Email: research@pplm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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
Active Comparator: 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	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Anticipated): July 17, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019P000848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No