Pharmacist Provision of Medication Abortion

NCT ID: NCT04956731

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2023-06-30

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.

Conditions

Abortion in First Trimester

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmacist provision of medication abortion

This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist.

Group Type: EXPERIMENTAL

Pharmacist Provision of Medication Abortion

Intervention Type: OTHER

Pharmacists providing start to finish medication abortions

Interventions

Pharmacist Provision of Medication Abortion

Pharmacists providing start to finish medication abortions

Intervention Type: OTHER

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:

3. Hepatic or renal failure

4. History of solid organ transplant

5. 4 or more cesarean sections

6. Allergy to NSAIDs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sarah Averbach, MD MAS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Averbach, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Health

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 38065286 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://doi.org/10.1016/j.contraception.2023.110346

Pharmacist provision of medication abortion: A pilot study

Other Identifiers

210175

Identifier Type: -

Identifier Source: org_study_id