N/A
N=10
Pharmacist Provision of Medication Abortion
Abortion in First Trimester
Bottom Line
View on ClinicalTrials.gov: NCT04956731 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Completion of Medication Abortion — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacist Provision of Medication Abortion (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of Medication Abortion |
9 | — |
| SECONDARY Patient Satisfaction, # of Patients Reporting "Very Satisfied" |
9 | — |
| SECONDARY Pharmacist Experience |
— | — |
| SECONDARY Toolkit Changes |
— | — |
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.
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:
- 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:
- 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.
Data sourced from ClinicalTrials.gov (NCT04956731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.