Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463736
Status:
TERMINATED
Last Update Posted:
2016-08-19
First Post:
2007-04-19
Brief Title:
Magnesium Sulfate Versus Placebo for Tocolysis in PPROM
Sponsor:
Regional Obstetrical Consultants
Organization:
Regional Obstetrical Consultants
Study Overview
Official Title:
Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment proceeding too slowly
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs Antibiotics and antenatal steroids given to both groups
Detailed Description:
The majority of studies of the effectiveness of tocolysis with PPROM were in the 1980s prior to the commmon usage of antenatal steroids and prophylactic maternal antibiotics In most studies tocolysis was not attempted prior to the onset of labor in this group of women The ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit administration of steroids and maternal antibiotics is based primarily upon consensus not consistent scientific evidence
The purpose of this study which will randomize 128 subjects to tocolysis or no tocolysis is to prospectively assess whether short term 48 hr tocolysis affords benefit to women and babies between 26 and 32 weeks gestation with PPROM
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville All English and Spanish speaking women 18-45 years with PPROM and cervical dilation 4 will be eligible Women with suspected intrauterine infection positive fetal lung maturity or 6 hours tocolysis at time of admission will be excluded
Both groups of women will receive continuous fetal monitoring antibiotics and antenatal steroids if not previously administered Both groups will be evaluated every 2-4 hours for fetal and maternal well being Both groups will receive IVF at 125cchr and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 gramshr x 48 hrs
The purpose of this study which will randomize 128 subjects to tocolysis or no tocolysis is to prospectively assess whether short term 48 hr tocolysis affords benefit to women and babies between 26 and 32 weeks gestation with PPROM
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville All English and Spanish speaking women 18-45 years with PPROM and cervical dilation 4 will be eligible Women with suspected intrauterine infection positive fetal lung maturity or 6 hours tocolysis at time of admission will be excluded
Both groups of women will receive continuous fetal monitoring antibiotics and antenatal steroids if not previously administered Both groups will be evaluated every 2-4 hours for fetal and maternal well being Both groups will receive IVF at 125cchr and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 gramshr x 48 hrs
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