Abortion in First Trimester
Conditions
Keywords
medication abortion, no-test medication abortion, pharmacist
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.
Interventions
OTHERPharmacist Provision of Medication Abortion
Pharmacists providing start to finish medication abortions
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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: 1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Medication Abortion | 6 weeks | Negative Pregnancy Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction, # of Patients Reporting Very Satisfied | 2 weeks following completion of medication abortion | qualitative analysis of post abortion in depth interviews |
| Pharmacist Experience | 2 weeks following completion of all 10 medication abortion visits | qualitative analysis of post pilot in depth interviews |
| Toolkit Changes | 2 weeks following completion of all 10 medication abortion visits | per recommendation by participating pharmacists at post pilot in depth interviews |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist Provision of Medication Abortion This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist.
Pharmacist Provision of Medication Abortion: Pharmacists providing start to finish medication abortions | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pharmacist Provision of Medication Abortion |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Completion of Medication Abortion
Negative Pregnancy Test
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacist Provision of Medication Abortion | Completion of Medication Abortion | 9 Participants |
Secondary
Patient Satisfaction, # of Patients Reporting Very Satisfied
qualitative analysis of post abortion in depth interviews
Time frame: 2 weeks following completion of medication abortion
Population: only 9 of the 10 participants completed post-abortion interview
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacist Provision of Medication Abortion | Patient Satisfaction, # of Patients Reporting Very Satisfied | 9 Participants |
Secondary
Pharmacist Experience
qualitative analysis of post pilot in depth interviews
Time frame: 2 weeks following completion of all 10 medication abortion visits
Secondary
Toolkit Changes
per recommendation by participating pharmacists at post pilot in depth interviews
Time frame: 2 weeks following completion of all 10 medication abortion visits