Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502158
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Mifepristone vs Misoprostol
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks Gestation in an Academic Medical Center a Randomized Controlled Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care the proportion of patients who achieve successful cervical dilation will be different between the study groups
Detailed Description:
Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended Cervical preparation options include misoprostol mifepristone and cervical dilators Regimen choice is often guided by provider comfort preference or institutional guidelines Misoprostol offers the advantage of facilitating same-day procedures but side effects like pain and gastrointestinal symptoms can negatively affect patients experiences Furthermore using misoprostol can pose logistical challenges in hospital-based main operating room environments where abortions occur concurrently with all other surgical cases Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration which can pose logistical challenges
Several studies demonstrate mifepristones efficacy and safety as a cervical ripening agent for up to 16 weeks gestation however despite its effectiveness mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost Recent studies demonstrating mifepristones adjunctive benefit with osmotic dilators later in pregnancy however have broadened its use
While most abortion care in the United States occurs in outpatient settings about 3 occur in hospitals This is expected to increase as the Dobbs versus Jackson Womens Health Organization decision exacerbates disparities in abortion access In hospital-based abortion care particularly at academic centers providing abortion training there is a pressing need for innovative measures for cervical ripening The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist A paracervical block of 20cc 1 lidocaine with or without vasopressin will be administered in accordance with standard practices
Several studies demonstrate mifepristones efficacy and safety as a cervical ripening agent for up to 16 weeks gestation however despite its effectiveness mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost Recent studies demonstrating mifepristones adjunctive benefit with osmotic dilators later in pregnancy however have broadened its use
While most abortion care in the United States occurs in outpatient settings about 3 occur in hospitals This is expected to increase as the Dobbs versus Jackson Womens Health Organization decision exacerbates disparities in abortion access In hospital-based abortion care particularly at academic centers providing abortion training there is a pressing need for innovative measures for cervical ripening The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist A paracervical block of 20cc 1 lidocaine with or without vasopressin will be administered in accordance with standard practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None