Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT02633761
Status:
TERMINATED
Last Update Posted:
2019-02-11
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
Sponsor:
Gynuity Health Projects
Organization:
Study Overview
Official Title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
Status:
TERMINATED
Status Verified Date:
2019-01
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 primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.
Detailed Description:
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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 repeated doses of 200mcg buccal misoprostol given every 3 hours;
2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
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 repeated doses of 200mcg buccal misoprostol given every 3 hours;
2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
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?: