Clinical trial NCT05839899: Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location
Official title: Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Abortion
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who seek medication abortion early in pregnancy may have an ultrasound that does not show a pregnancy in the uterus. This is known as a "pregnancy of unknown location". These patients most likely have a pregnancy in the uterus that is too early to be seen on ultrasound, but it is possible that the pregnancy is not seen inside the uterus because it is outside of the uterus, known as an ectopic pregnancy. Patients with ectopic pregnancies are at risk for serious complications, and the medications used for medication abortion may not end an ectopic pregnancy.

Currently, at Planned Parenthood League of Massachusetts (PPLM), patients seeking medication abortion, including some patients with a pregnancy of unknown location, are given mifepristone to begin the medication abortion at the clinic and then one dose of misoprostol to take at home to cause the pregnancy to pass. However, research suggests that a second dose of misoprostol leads to a higher rate of completed abortion for certain patients.

This research is being conducted to learn if two doses of the at-home misoprostol during the medication abortion process leads to a higher rate of completed abortion for patients with pregnancy of unknown location. In this study, all participants will receive mifepristone as they normally would. Then, participants will be randomly assigned to receive either one dose of misoprostol or two doses of misoprostol.


Eligibility criteria: Inclusion Criteria:

* Positive urine or serum hCG test
* No evidence of gestational sac on transvaginal ultrasound
* No evidence of ectopic pregnancy on transvaginal ultrasound
* Desire for same-day start medication abortion as method of pregnancy termination
* Eligible for same-day-start medication abortion based on PPLM clinical guidelines at the time of enrollment
* English-speaking

Exclusion Criteria:

* Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines at the time of enrollment

  o PPLM clinical guidelines for medication abortion currently exclude those with chronic adrenal failure, concurrent long-term corticosteroid use, hemorrhagic disorders or concurrent anti-coagulation, porphyria, allergies to mifepristone or misoprostol, or an IUD in place.
* Ineligible for same-day-start medication abortion with PUL based on PPLM clinical guidelines and clinician assessment at the time of enrollment

  o PPLM clinical guidelines for initiating medication abortion with PUL currently exclude those with major ectopic risk factors (IUD in situ, prior ectopic, history of tubal surgery) or symptoms concerning for ectopic (i.e. pain, bleeding) per clinician discretion.
* Age less than 18 years old
* Prior participation in this study
* Anticipated inability to adhere to follow up protocol or complete the survey
* Unable to give informed consent or to complete all study procedures

Primary outcomes:
measure: Recruitment rates, to determine feasibility of recruitment
timeFrame: 1 year
measure: Acceptability of second dose of misoprostol
timeFrame: 1 month per subject, 1 year for all subjects
measure: Refusal rates, to determine feasibility of recruitment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
References: