Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes

Conditions
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Preterm Premature Rupture of Membranes

Intervention / Treatment
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* Drug: Magnesium sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking preterm premature rupture of membranes 26 - 32.6 weeks gestation cervical dilation </= 4 cm Exclusion Criteria: suspected intrauterine or intraamniotic infection > 6 hours of tocolysis prior to admission positive fetal lung maturity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulfate<br>x 48 hours IV | Drug: Magnesium sulfate<br> <br> |
| Placebo Comparator: Normal saline<br>x 48 hours IV | Drug: Magnesium sulfate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hours of latency to delivery | from start of study drug to delivery | 0 hours to > 168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal postpartum length of stay | from start of study drug to delivery | 0 hours to > 168 hours | 
| maternal infection rates | from start of study drug to maternal discharge from hospital | 0 hours to > 168 hours | 
| neonatal ventilator days | from delivery to 28 days of life | 0 to 28 days | 
| neonatal early onset infection | from delivery to 28 days of life | 0 to 28 days | 
| neonatal length of stay | from delivery to 28 days of life | 0 to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short term tocolysis, preterm premature rupture of membranes