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Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

This study has been terminated.
(enrollment proceeding too slowly)
Sponsor:
Information provided by (Responsible Party):
Lorrie Mason, Regional Obstetrical Consultants
ClinicalTrials.gov Identifier:
NCT00463736
First received: April 19, 2007
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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
Preterm Premature Rupture of Membranes
Drug: Magnesium sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes

Resource links provided by NLM:


Further study details as provided by Regional Obstetrical Consultants:

Primary Outcome Measures:
  • hours of latency to delivery [ Time Frame: 0 hours to > 168 hours ] [ Designated as safety issue: No ]
    from start of study drug to delivery


Secondary Outcome Measures:
  • maternal postpartum length of stay [ Time Frame: 0 hours to > 168 hours ] [ Designated as safety issue: No ]
    from start of study drug to delivery

  • maternal infection rates [ Time Frame: 0 hours to > 168 hours ] [ Designated as safety issue: No ]
    from start of study drug to maternal discharge from hospital

  • neonatal ventilator days [ Time Frame: 0 to 28 days ] [ Designated as safety issue: No ]
    from delivery to 28 days of life

  • neonatal early onset infection [ Time Frame: 0 to 28 days ] [ Designated as safety issue: No ]
    from delivery to 28 days of life

  • neonatal length of stay [ Time Frame: 0 to 28 days ] [ Designated as safety issue: No ]
    from delivery to 28 days of life


Enrollment: 4
Study Start Date: April 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium sulfate
x 48 hours IV
Drug: Magnesium sulfate
Placebo Comparator: Normal saline
x 48 hours IV
Drug: Magnesium sulfate

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463736

Locations
United States, Tennessee
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Regional Obstetrical Consultants
Investigators
Principal Investigator: Christian M Briery, MD Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
  More Information

Responsible Party: Lorrie Mason, Christian Briery MD, Regional Obstetrical Consultants
ClinicalTrials.gov Identifier: NCT00463736     History of Changes
Other Study ID Numbers: 07-006 
Study First Received: April 19, 2007
Last Updated: August 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Regional Obstetrical Consultants:
short term tocolysis
preterm premature rupture of membranes

Additional relevant MeSH terms:
Premature Birth
Rupture
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 23, 2016