Pharmacist Provision of Medication Abortion

Abortion in First Trimester Clinical Trial

Official title: Pharmacist Provision of Medication Abortion Pilot

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Abortion in First Trimester

• NCT number: NCT04956731
• Study type: Interventional
• Source: University of California, San Diego
• Contact: Selina Sandoval, MD
• Phone: 9162084861
• Email: smsandoval@ucsd.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Completion date: September 1, 2022