Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306462
Status:
TERMINATED
Last Update Posted:
2009-11-09
First Post:
2006-03-21
Brief Title:
Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 67 Weeks Gestation
Status:
TERMINATED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment in past year lack of interest
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Hypothesis
Acute tocolysis 48 hours using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 67 weeks gestation
Acute tocolysis 48 hours using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 67 weeks gestation
Detailed Description:
Primary Objective
To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at 37 weeks in women with preterm labor between 24 and 32 67 weeks gestation
Secondary Objective
1 To compare maternal side effects between the two tocolytic agents
2 To compare neonatal morbidities between the two study groups
To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at 37 weeks in women with preterm labor between 24 and 32 67 weeks gestation
Secondary Objective
1 To compare maternal side effects between the two tocolytic agents
2 To compare neonatal morbidities between the two study groups
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