NCT03320057

Brief Summary

This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2018

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

September 26, 2017

Results QC Date

May 21, 2021

Last Update Submit

June 18, 2021

Conditions

Pregnancy RelatedAbortion Early

Keywords

medication abortionmifepristone

Outcome Measures

Primary Outcomes (2)

  • Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex

    Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex.

    End of the study, month 24

  • Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex

    Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?" in endline survey

    End of the study, month 24

Secondary Outcomes (4)

  • Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy

    Day 2 following initial medication abortion visit

  • Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion

    Up to 6 weeks after initial visit

  • Number of Participants With an Adverse Event

    Up to 6 weeks after initial visit

  • Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion

    Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge

Study Arms (2)

Medication abortion patients

EXPERIMENTAL

Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)

Drug: Mifepristone

Pharmacists

OTHER

Pharmacists providing services at one of the study pharmacies during the study

Other: Training on mifepristone dispensing

Interventions

MifepristoneDRUG

Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit

Medication abortion patients
Training on mifepristone dispensingOTHER

Pharmacists were offered a training on medication abortion and mifepristone dispensing

Pharmacists

Eligibility Criteria

Age15 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales seeking medication abortion
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women seeking medication abortion through 70 days gestation
  • Eligible for Mifeprex® at a study clinical site
  • English or Spanish speaking
  • Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone

You may not qualify if:

  • Not pregnant
  • Not seeking medication abortion
  • Under the age of 15
  • Contraindications for medication abortion
  • All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Obstetrics and Gynecology Family Planning Clinic at University of California Davis

Sacramento, California, 95817, United States

Location

Women's Health Services at University of California San Diego

San Diego, California, 92103, United States

Location

Kaiser Permanente Northern California

San Francisco, California, 94115, United States

Location

Mt. Zion Women's Options Clinic, University

San Francisco, California, 94115, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

Tacoma, Washington, 98405, United States

Location

Related Publications (2)

  • Kaller S, Morris N, Biggs MA, Baba CF, Rafie S, Raine-Bennett TR, Creinin MD, Berry E, Micks EA, Meckstroth KR, Averbach S, Grossman D. Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion. J Am Pharm Assoc (2003). 2021 Nov-Dec;61(6):785-794.e1. doi: 10.1016/j.japh.2021.06.017. Epub 2021 Jun 18.

    PMID: 34281806DERIVED

  • Grossman D, Baba CF, Kaller S, Biggs MA, Raifman S, Gurazada T, Rafie S, Averbach S, Meckstroth KR, Micks EA, Berry E, Raine-Bennett TR, Creinin MD. Medication Abortion With Pharmacist Dispensing of Mifepristone. Obstet Gynecol. 2021 Apr 1;137(4):613-622. doi: 10.1097/AOG.0000000000004312.

    PMID: 33706339DERIVED

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

We aimed to recruit 300-350 patients for this study. We had to stop recruitment early because of the COVID-19 pandemic, reaching 89% of our planned minimum sample size.

Results Point of Contact

Title
Shelly Kaller
Organization
University of California San Francisco
shelly.kaller@ucsf.edu
510-986-8945

Study Officials

  • Daniel Grossman, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Prospective cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 25, 2017

Study Start

June 1, 2018

Primary Completion

July 4, 2020

Study Completion

July 4, 2020

Last Updated

July 12, 2021

Results First Posted

July 12, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(6)