Abortion Early
Conditions
Brief summary
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.
Detailed description
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion (MA) provision service. The foundation of this service will be a website that provides information combined with a linked screening questionnaire. The questionnaire will be designed to collect the information recommended by current MA guidelines for history-based MA eligibility assessment. If the patient's responses meet specified criteria, the questionnaire will be sent to a study clinician, who will then determine whether a real-time clinical consultation or facility-based tests are needed. If the clinician decides that they are not, treatment will be provided accordingly. The primary goal of the study is to collect preliminary data on feasibility of the approach, abortion outcomes, and participant satisfaction. The investigators will use these data to determine whether to proceed with further development of asynchronous MA provision.
Interventions
Asynchronous screening
Sponsors
Stanford University
Planned Parenthood of the Rocky Mountains
Planned Parenthood North Central States
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Case series study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • Has reviewed the study website * Can speak and read English * Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal * Is at least 18 years old * Is pregnant with a gestational age of ≤54 days from last menstrual period * Desires MA * Has not had an ultrasound in the current pregnancy (see below) * Has no symptoms of or risk factors for ectopic pregnancy * Has no medical contraindications to MA, specifically: * Hemorrhagic disorder or concurrent anticoagulant therapy * Chronic adrenal failure * Concurrent long-term systemic corticosteroid therapy * Inherited porphyria * Allergy to mifepristone or misoprostol, or other prostaglandin * Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 12 months | Proportion of treated participants with SAE (serious adverse effects) related to the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of participant questions | 12 months | The proportion of participants who have questions after completing the questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who liked the service | 12 months | Participant satisfaction upon exiting study evaluated using a participant satisfaction survey questionnaire |
Countries
United States
Outcome results
None listed