Medication Abortion for Pregnancy of Unknown Location

NCT04026789 — Not applicable, Unknown, 57 participants, Planned Parenthood League of Massachusetts

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RegistryNCT04026789, acronym MAPUL
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment57 (Estimated)
SponsorPlanned Parenthood League of Massachusetts (Other)
ConditionsPregnancy Related
InterventionsSame-day-start, Delay-for-diagnosis (Other)
Datesstart 2019-07-22, primary completion 2021-07-17 (estimated), completion 2021-07-31 (estimated), first posted 2019-07-19, last updated 2020-10-05
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Pregnancy Related All trials of Same-day-start All trials of Delay-for-diagnosis

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Same-day-startActive comparatorOther: Same-day-startPatients 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-diagnosisActive comparatorOther: Delay-for-diagnosisPatients 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
  • 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
  • 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

+Outcome measures

Primary outcomes

  • Time to completed abortion [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 outcomes

  • Number of participants with complete expulsion of pregnancy without surgical intervention [14 days after initiation of medical abortion]: Efficacy of medical abortion, defined as number of participants with complete expulsion of pregnancy without surgical intervention
  • Time to diagnosis of pregnancy outcome [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
  • Rate of ectopic pregnancy [Within 2 weeks of identification of pregnancy of unknown location on ultrasound]: Rate of ectopic pregnancy among entire study population
  • Percent of participants who complete follow-up and confirm complete abortion [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

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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)

FacilityCityCountryStatus
PPLMBoston, MassachusettsUnited StatesRecruiting