Medication Abortion for Pregnancy of Unknown Location

NCT04026789 | Unknown

• 1 other identifier: 2019P000848
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants with complete expulsion of pregnancy without surgical intervention

  14 days after initiation of medical abortion

• Time to diagnosis of pregnancy outcome

  Within 2 weeks of identification of pregnancy of unknown location on ultrasound

• Rate of ectopic pregnancy

  Within 2 weeks of identification of pregnancy of unknown location on ultrasound

• Percent of participants who complete follow-up and confirm complete abortion

  Within 1 month of identification of pregnancy of unknown location on ultrasound

Study Arms (2)

Same-day-start

ACTIVE COMPARATOR

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

Delay-for-diagnosis

ACTIVE COMPARATOR

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

Interventions

Same-day-start OTHER

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

Same-day-start

Delay-for-diagnosis OTHER

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

Delay-for-diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive urine or serum hCG test
• No evidence of gestational sac on transvaginal ultrasound
• Desire for medication abortion as method of pregnancy termination

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead

Study Sites (1)

PPLM

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Principal Investigator

CONTACT

6176161600; research@pplm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: July 22, 2019
• Primary Completion: July 17, 2021
• Study Completion: July 31, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)