Pharmacist Provision of Medication Abortion
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|ClinicalTrials.gov Identifier: NCT04956731|
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : August 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Abortion in First Trimester||Other: Pharmacist Provision of Medication Abortion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacist Provision of Medication Abortion Pilot|
|Actual Study Start Date :||January 12, 2022|
|Actual Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Pharmacist provision of medication abortion
This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist.
Other: Pharmacist Provision of Medication Abortion
Pharmacists providing start to finish medication abortions
- Completion of Medication Abortion [ Time Frame: 6 weeks ]Negative Pregnancy Test
- Patient Satisfaction [ Time Frame: 2 weeks following completion of medication abortion ]qualitative analysis of post abortion in depth interviews
- Pharmacist Experience [ Time Frame: 2 weeks following completion of all 10 medication abortion visits ]qualitative analysis of post pilot in depth interviews
- Toolkit changes [ Time Frame: 2 weeks following completion of all 10 medication abortion visits ]per recommendation by participating pharmacists at post pilot in depth interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956731
|Contact: Selina Sandoval, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92103|
|Contact: Selina Sandoval 916-208-4861 email@example.com|