Pharmacist Provision of Medication Abortion

NCT04956731 | Completed Results

• 1 other identifier: 210175
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion in First Trimester

Keywords

medication abortion, no-test medication abortion, pharmacist

Outcome Measures

Primary Outcomes (1)

• Completion of Medication Abortion

  Negative Pregnancy Test

  6 weeks

Secondary Outcomes (3)

• Patient Satisfaction, # of Patients Reporting "Very Satisfied"

  2 weeks following completion of medication abortion

• Pharmacist Experience

  2 weeks following completion of all 10 medication abortion visits

• Toolkit Changes

  2 weeks following completion of all 10 medication abortion visits

Study Arms (1)

Pharmacist provision of medication abortion

EXPERIMENTAL

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

Interventions

Pharmacist Provision of Medication Abortion OTHER

Pharmacists providing start to finish medication abortions

Pharmacist provision of medication abortion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any contraindications to medication abortion, as reported on their medical history. These contraindicated include:
• Hemorrhagic bleeding disorder
• Current anticoagulation therapy
• Chronic adrenal failure
• Long-term systemic corticosteroid therapy
• 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:
• Hepatic or renal failure
• History of solid organ transplant
• or more cesarean sections
• Allergy to NSAIDs.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 38065286 BACKGROUND

Related Links

• Pharmacist provision of medication abortion: A pilot study

Results Point of Contact

• Title: Office of Clinical Trials Administration
• Organization: University of California, San Diego

octa@ucsd.edu

858-822-2940

Study Officials

• Sarah Averbach, MD, MAS

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: January 12, 2022
• Primary Completion: August 5, 2022
• Study Completion: June 30, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)