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Sponsored by: |
Regional Obstetrical Consultants |
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Information provided by: | Regional Obstetrical Consultants |
ClinicalTrials.gov Identifier: | NCT00463736 |
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.
Condition | Intervention |
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Preterm Premature Rupture of Membranes |
Drug: Magnesium sulfate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes |
Estimated Enrollment: | 128 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2009 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lorrie A Mason, MSN | 423 826-8086 | lorrie@rocob.com |
United States, Tennessee | |
Regional Obstetrical Consultants | Recruiting |
Chattanooga, Tennessee, United States, 37403 | |
Contact: Lorrie A Mason, MSN 423-826-8086 lorrie@rocob.com | |
Sub-Investigator: Shawn P Stallings, MD | |
Sub-Investigator: Joseph H Kipikasa, MD | |
Sub-Investigator: C David Adair, MD | |
Sub-Investigator: Carlos Torres, MD | |
Sub-Investigator: Brandon Riggan, MD |
Principal Investigator: | Christian M Briery, MD | Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department |
Study ID Numbers: | 07-006 |
Study First Received: | April 19, 2007 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00463736 |
Health Authority: | United States: Institutional Review Board |
short term tocolysis preterm premature rupture of membranes |
Calcium, Dietary Pregnancy Complications Magnesium Sulfate Wounds and Injuries |
Obstetric Labor Complications Disorders of Environmental Origin Rupture Fetal Membranes, Premature Rupture |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Calcium Channel Blockers Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |