University of California, San Diego
La Jolla, California, 92103, United States
NCT Number: NCT04956731
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.
Looking for future studies?
Notify Me18 year–50 year
Female
Interventional
Not applicable
La Jolla, California, 92103, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
d) Allergy to misoprostol or mifepristone
Pharmacists providing start to finish medication abortions
Time frame: 6 weeks
Negative Pregnancy Test
Time frame: 2 weeks following completion of medication abortion
qualitative analysis of post abortion in depth interviews
Time frame: 2 weeks following completion of all 10 medication abortion visits
qualitative analysis of post pilot in depth interviews
Time frame: 2 weeks following completion of all 10 medication abortion visits
per recommendation by participating pharmacists at post pilot in depth interviews
University of California, San Diego
Other
Pharmacist Provision of Medication Abortion Pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05320432
Abortion in First Trimester, Neurologic Manifestations
Palo Alto, California, United States
View Trial DetailsNCT05182008
Abortion Early, Abortion in First Trimester
Halifax, Nova Scotia, Canada
View Trial DetailsNCT03636451
Abortion Early, Abortion in First Trimester
La Jolla, California, United States
View Trial DetailsNCT05469594
Abortion in First Trimester, Abortion, Second Trimester
View Trial Details