Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT02342002
Status:
TERMINATED
Last Update Posted:
2019-01-15
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Sponsor:
Gynuity Health Projects
Organization:
Study Overview
Official Title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
Detailed Description:
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.
Study Oversight
Has Oversight DMC:
True
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?: