Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 3:48 PM
Study NCT ID:
NCT05781061
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MA-ASAP at Independent Abortion Clinics: A Demonstration Project
Sponsor:
Gynuity Health Projects
Organization:
Study Overview
Official Title:
Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: