Magnesium Sulfate Versus Placebo for Tocolysis in PPROM
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|ClinicalTrials.gov Identifier: NCT00463736|
Recruitment Status : Terminated (enrollment proceeding too slowly)
First Posted : April 20, 2007
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Preterm Premature Rupture of Membranes||Drug: Magnesium sulfate||Not Applicable|
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 125cc/hr, and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 grams/hr x 48 hrs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Active Comparator: Magnesium sulfate
x 48 hours IV
Drug: Magnesium sulfate
Placebo Comparator: Normal saline
x 48 hours IV
Drug: Magnesium sulfate
- hours of latency to delivery [ Time Frame: 0 hours to > 168 hours ]from start of study drug to delivery
- maternal postpartum length of stay [ Time Frame: 0 hours to > 168 hours ]from start of study drug to delivery
- maternal infection rates [ Time Frame: 0 hours to > 168 hours ]from start of study drug to maternal discharge from hospital
- neonatal ventilator days [ Time Frame: 0 to 28 days ]from delivery to 28 days of life
- neonatal early onset infection [ Time Frame: 0 to 28 days ]from delivery to 28 days of life
- neonatal length of stay [ Time Frame: 0 to 28 days ]from delivery to 28 days of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463736
|United States, Tennessee|
|Regional Obstetrical Consultants|
|Chattanooga, Tennessee, United States, 37403|
|Principal Investigator:||Christian M Briery, MD||Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department|