Pharmacist Provision of Medication Abortion

Abortion in First Trimester Clinical Trial

Official title:

Pharmacist Provision of Medication Abortion Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956731
• Other study ID #: 210175
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2022
• Source: University of California, San Diego
• Contact: Selina Sandoval, MD
• Phone: 9162084861
• Email: smsandoval[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 patients will complete a brief 5-10 minute telehealth visit with a registered physician Mifepristone prescriber. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Other:
• Pharmacist Provision of Medication Abortion
Pharmacists providing start to finish medication abortions

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Medication Abortion	Negative Pregnancy Test	6 weeks
Secondary	Patient Satisfaction	qualitative analysis of post abortion in depth interviews	2 weeks following completion of medication abortion
Secondary	Pharmacist Experience	qualitative analysis of post pilot in depth interviews	2 weeks following completion of all 10 medication abortion visits
Secondary	Toolkit changes	per recommendation by participating pharmacists at post pilot in depth interviews	2 weeks following completion of all 10 medication abortion visits