Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 2:25 AM
Study NCT ID:
NCT01869361
Status:
WITHDRAWN
Last Update Posted:
2021-12-07
First Post:
2013-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indomethacin for Tocolysis of Preterm Labor
Sponsor:
MetroHealth Medical Center
Organization:
Study Overview
Official Title:
Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis
Status:
WITHDRAWN
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to much lower than expected numbers of eligible patients and lack of PI time, the study was not started.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Indomethacin for tocolysis for 48 hours vs placebo
Detailed Description:
Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy.
Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.
Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: