Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-02-11 @ 12:45 AM
Study NCT ID:
NCT04242212
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
Sponsor:
Ipas
Organization:
Study Overview
Official Title:
A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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:
The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.
Detailed Description:
Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (\<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.
The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.
The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.
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?: