Clinical trial NCT04956731: Pharmacist Provision of Medication Abortion
Official title: Pharmacist Provision of Medication Abortion Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Keywords: medication abortion, no-test medication abortion, pharmacist
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This will be a pilot study among two pharmacists providing start to finish medication abortions to 10 patients utilizing a previously created toolkit. Following completion of the pilot, we will perform in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences with pharmacist provision of medication abortion. In addition, we will elicit feedback about ways to refine the toolkit to support the scale-up of pharmacist provision of medication abortion in the future.

Detailed description: We will conduct a 'proof of concept' pilot study. Participating patients will be counseled by a trained pharmacist who will provide Mifepristone 200 mg and two doses of 800 mcg of Misoprostol. Patients will be instructed to take the 800 mcg of misoprostol buccally 24-48 hours after their Mifepristone. Patients whose estimated gestational age is between 64 and 70 days will be instructed to take the additional dose of 800 mcg of misoprostol 4 hours after the first dose. Patients who estimated gestational age is 63 days or less will be instructed to take the additional dose of 800 mcg of misoprostol if they do not experience at least moderate bleeding within the first 24 hours following their first misoprostol dose.

The standard Mifepristone consent form will be signed at this time and the patient will then be instructed to take the Mifepristone orally.

Participants will be contacted one week after receiving treatment by the providing pharmacist. If the participant history suggests concern for a continuing pregnancy, ectopic pregnancy or worrisome bleeding, they will be scheduled for in person evaluation. If the participant does not indicate any concern, they will be instructed to use the high sensitivity urine pregnancy test four weeks after taking their misoprostol. If the participant's first high sensitivity urine pregnancy test is positive but they have no symptoms concerning for ongoing pregnancy, they will be instructed to perform a second, high sensitivity urine pregnancy test in one week. If the second, high sensitivity urine pregnancy test is also positive, the patient will be evaluated in person.

We will continue our study by performing in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences and elicit feedback about ways to refine the toolkit. We will follow a prepared interview guide.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Pregnancy must be confirmed by either patient report of a positive urine pregnancy test, serum pregnancy test or ultrasound
* Patient's last menstrual period (LMP) must be less than 70 days before the anticipated date of mifepristone administration
* Patient must be certain of their LMP within 7 days and have regular menses
* Patient has no symptoms or risk factors for ectopic pregnancy including bleeding or spotting in the week before their visit, prior ectopic pregnancy, significant pelvic pain the last week, prior permanent contraception or tubal surgery, current intrauterine device (IUD) in place or IUD in place at time of conception.

Exclusion Criteria:

* Any contraindications to medication abortion, as reported on their medical history. These contraindicated include:

  1. Hemorrhagic bleeding disorder
  2. Current anticoagulation therapy
  3. Chronic adrenal failure
  4. Long-term systemic corticosteroid therapy
  5. Inherited porphyria

  d) Allergy to misoprostol or mifepristone
* Any patient with complex medical conditions will also be excluded from this initial pilot. These medical conditions include:

  1. Poorly controlled hypertension as defined a history of systolic blood pressure \>160 or diastolic blood pressure \>110 or patients requiring two or more antihypertensive medication to control their blood pressure. This will be exclusion criteria for the study but it not a standard exclusion criteria for medication abortion
  2. Poorly controlled diabetes as defined by a known history of Type 1 or Type 2 diabetes with history of finger stick blood sugar \>200 or HbA1c\>10 in the last 6 months. This will be exclusion criteria for the study but it not a standard exclusion criteria for medication abortion
  3. Hepatic or renal failure
  4. History of solid organ transplant
  5. 4 or more cesarean sections
  6. Allergy to NSAIDs.

Primary outcomes:
measure: Completion of Medication Abortion
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient Satisfaction, # of Patients Reporting "Very Satisfied"
timeFrame: 2 weeks following completion of medication abortion
measure: Pharmacist Experience
timeFrame: 2 weeks following completion of all 10 medication abortion visits
measure: Toolkit Changes
timeFrame: 2 weeks following completion of all 10 medication abortion visits
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UC San Diego Health
name: Sarah Averbach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandoval S, Rafie S, Kully G, Mody S, Averbach S. Pharmacist provision of medication abortion: A pilot study. Contraception. 2024 Mar;131:110346. doi: 10.1016/j.contraception.2023.110346. Epub 2023 Dec 7.