Medication Abortion for Pregnancy of Unknown Location

Pregnancy Related Clinical Trial

— MAPUL  

Official title:

Medication Abortion for Pregnancy of Unknown Location

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026789
• Other study ID #: 2019P000848
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2020
• Source: Planned Parenthood League of Massachusetts
• Contact: Principal Investigator
• Phone: 6176161600
• Email: research[@]pplm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: July 31, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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
• 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

Locations

Country	Name	City	State
United States	PPLM	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Rate of ectopic pregnancy	Rate of ectopic pregnancy among entire study population	Within 2 weeks of identification of pregnancy of unknown location on ultrasound
Secondary	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