Medication Abortion for Pregnancy of Unknown Location (MAPUL)

Planned Parenthood League of Massachusetts

Status: Unknown

Conditions: Pregnancy Related

Treatments: Other: Same-day-start; Other: Delay-for-diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04026789

2019P000848

Details and patient eligibility

About

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.

Enrollment: 57 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Same-day-start

Active Comparator group

Description:

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

Treatment:

Other: Same-day-start

Delay-for-diagnosis

Active Comparator group

Description:

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

Treatment:

Other: Delay-for-diagnosis