Medication Abortion With Autonomous Self-Assessment Project

Abortion Early Clinical Trial

— MA-ASAP  

Official title:

Medication Abortion With Autonomous Self-Assessment Project: Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05278780
• Other study ID #: 1054
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: March 2023
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Abortion Early

Intervention

Other:
• Screening for eligibility
Asynchronous screening

Locations

Country	Name	City	State
United States	Planned Parenthood of the Rocky Mountains	Boulder	Colorado
United States	Planned Parenthood North Central States	Saint Paul	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Gynuity Health Projects	Planned Parenthood North Central States, Planned Parenthood of the Rocky Mountains, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants who liked the service	Participant satisfaction upon exiting study evaluated using a participant satisfaction survey questionnaire	12 months
Primary	Incidence of Treatment-Emergent Adverse Events	Proportion of treated participants with SAE (serious adverse effects) related to the study	12 months
Secondary	Incidence of participant questions	The proportion of participants who have questions after completing the questionnaire	12 months