Medication Abortion for Pregnancy of Unknown Location

Planned Parenthood League of Massachusetts57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pregnancy Related

Interventions

Same-day-startOTHER

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-diagnosisOTHER

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

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PPLM

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: through study completion, an average of two weeks

Secondary Outcomes

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

Time frame: 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

Time frame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound

Rate of ectopic pregnancy

Rate of ectopic pregnancy among entire study population

Time frame: 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

Time frame: Within 1 month of identification of pregnancy of unknown location on ultrasound

Central Contacts

Principal Investigator

CONTACT

6176161600 research@pplm.org

Data from ClinicalTrials.gov

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