MA-ASAP at Independent Abortion Clinics: A Demonstration Project

Abortion Early Clinical Trial

Official title:

Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781061
• Other study ID #: 1059
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2023
• Source: Gynuity Health Projects
• Contact: Elizabeth Raymond, MD
• Phone: (212) 448-1230
• Email: eraymond[@]gynuity.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.

Description:

In this study, the investigators propose to conduct a parallel study to the MA-ASAP pilot study (ClinicalTrials.gov Identifier: NCT05278780) at one or more independent abortion clinics. This new study will be similar in structure to pilot study, except that all completed screening questionnaires will be sent to the study site rather than only those deemed eligible according a computer algorithm. The investigators expect that this change will better serve the needs of both clinics and patients, and it will also allow us to assess whether the algorithm is overly restrictive, i.e., whether it is excluding patients who are in fact eligible for MA. The primary goal of the study is to collect data on feasibility of the approach and safety. Secondarily, the investigators aim to assess the ability of a defined set of responses to the screening questionnaire to predict the clinician's decision about whether a clinical consultation is needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 old enough to consent to abortion and study participation without parental consent in the study state

• Has reviewed the study website

• Has had a positive pregnancy test

• Has signed the study informed consent form (ICF), which will be included within the questionnaire

• Is pregnant with a gestational age of =77 days from last menstrual period

• Desires MA

• 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 not asked by the site to have a synchronous consultation with clinician OR facility-based tests such as ultrasound, laboratory tests, examination, etc.

• Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.

Related Conditions & MeSH terms

• Abortion Early

Intervention

Other:
• Screening for Eligibility
Asynchronous Screening for MA Eligibility

Locations

Country	Name	City	State
United States	All Families Healthcare	Whitefish	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	All Families Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of participant questions	The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.	6 months
Primary	Proportion of participants that are followed through the study	The numbers and proportions of people who complete the questionnaire once initiated, are reached by study staff after submitting a completed questionnaire, and are ultimately followed through the study.	6 months
Primary	Incidence of reported problems by site staff	Problems with the study process as reported by site staff	6 months
Primary	Study site satisfaction (self-reported)	Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.	6 months
Primary	Incidence of Treatment-Emergent Adverse Events	Proportion of treated participants with SAE related to the study	6 months
Secondary	Efficacy of computer algorithm to determine MA eligibility	We will estimate the predictive value of this algorithm for selecting participants who were deemed eligible for MA or ultimately did receive treatment without a synchronous consultation or facility-based tests	6 months