Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medication Abortion for Pregnancy of Unknown Location (MAPUL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04026789
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Other: Same-day-start Other: Delay-for-diagnosis Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medication Abortion for Pregnancy of Unknown Location
Estimated Study Start Date : July 19, 2019
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 31, 2020

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




Primary Outcome Measures :
  1. Time to completed abortion [ Time Frame: through study completion, an average of two weeks ]
    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


Secondary Outcome Measures :
  1. Complete expulsion of pregnancy without surgical intervention [ Time Frame: 14 days after initiation of medical abortion ]
    Efficacy of medical abortion, defined as complete expulsion of pregnancy without surgical intervention

  2. Time to diagnosis of pregnancy outcome [ Time Frame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound ]
    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

  3. Rate of ectopic pregnancy [ Time Frame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound ]
    Rate of ectopic pregnancy among entire study population

  4. Percent of participants who complete follow-up and confirm complete abortion [ Time Frame: Within 1 month of identification of pregnancy of unknown location on ultrasound ]
    Percent of participants who adhered to recommended follow-up plan and confirmed a complete abortion through ultrasound or hCG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026789


Contacts
Layout table for location contacts
Contact: Principal Investigator 6176161600 research@pplm.org

Locations
Layout table for location information
United States, Massachusetts
PPLM Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Research Manager    617-616-1600    research@pplm.org   
Sponsors and Collaborators
Planned Parenthood League of Massachusetts

Layout table for additonal information
Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT04026789     History of Changes
Other Study ID Numbers: 2019P000848
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data with any other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No