Abortion in First TrimesterNCT04956731
Pharmacist Provision of Medication Abortion
A study testing Pharmacist Provision of Medication Abortion in people with Abortion in First Trimester, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Pharmacist Provision of Medication Abortion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- Allergy to misoprostol or mifepristone
- Any patient with complex medical conditions will also be excluded from this initial pilot. These medical conditions include:
- Poorly controlled hypertension as defined a history of systolic blood pressure >160 or diastolic blood pressure >110 or patients requiring two or more antihypertensive medication to control their blood pressure. This will be exclusion criteria for the study but it not a standard exclusion criteria for medication abortion
- Poorly controlled diabetes as defined by a known history of Type 1 or Type 2 diabetes with history of finger stick blood sugar >200 or HbA1c>10 in the last 6 months. This will be exclusion criteria for the study but it not a standard exclusion criteria for medication abortion
- Hepatic or renal failure
- History of solid organ transplant
- 4 or more cesarean sections
- Allergy to NSAIDs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92103
About this study
Official title: Pharmacist Provision of Medication Abortion Pilot
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.
Read the 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
- Being tested
- Pharmacist Provision of Medication Abortion
- Keywords
- medication abortion, no-test medication abortion, pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Provision of Medication AbortionOther
Pharmacists providing start to finish medication abortions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pharmacist Provision of Medication Abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Medication Abortion
Negative Pregnancy Test
Measured: 6 weeks
Secondary outcomes (3)
Patient Satisfaction, # of Patients Reporting "Very Satisfied"
qualitative analysis of post abortion in depth interviews
Measured: 2 weeks following completion of medication abortion
Pharmacist Experience
qualitative analysis of post pilot in depth interviews
Measured: 2 weeks following completion of all 10 medication abortion visits
Toolkit Changes
per recommendation by participating pharmacists at post pilot in depth interviews
Measured: 2 weeks following completion of all 10 medication abortion visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start12 Jan 2022
- Primary completion5 Aug 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Sarah Averbach, MD, MAS, Principal investigator, UC San Diego Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956731
- Sponsor's protocol ID
- 210175
- Status last verified
- May 2024
- First submitted
- 30 Jun 2021
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38065286
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Provision of Medication Abortion Pilot
- ClinicalTrials.gov ID
- NCT04956731
- Acronym / sponsor ID
- 210175
- Conditions
- Abortion in First Trimester
- Keywords
- medication abortion, no-test medication abortion, pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist provision of medication abortion | Experimental | Other: Pharmacist Provision of Medication AbortionThis is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Any contraindications to medication abortion, as reported on their medical history. These contraindicated include:
- Any patient with complex medical conditions will also be excluded from this initial pilot. These medical conditions include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist Provision of Medication AbortionPharmacists providing start to finish medication abortions | Other | Pharmacist provision of medication abortion |
Primary outcome
Completion of Medication Abortion
Time frame: 6 weeks
Negative Pregnancy Test
3 secondary outcomes
Patient Satisfaction, # of Patients Reporting "Very Satisfied"
Time frame: 2 weeks following completion of medication abortion
Pharmacist Experience
Time frame: 2 weeks following completion of all 10 medication abortion visits
Toolkit Changes
Time frame: 2 weeks following completion of all 10 medication abortion visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38065286Sandoval 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.
- Pharmacist provision of medication abortion: A pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Averbach, MD, MAS principal investigator
UC San Diego Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Provision of Medication Abortion in people with Abortion in First Trimester, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Medication Abortion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.