Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

Not Applicable

Terminated

• Conditions: Preterm Premature Rupture of Membranes
• Interventions: Drug: Magnesium sulfate

• Registration Number: NCT00463736
• Lead Sponsor: Regional Obstetrical Consultants

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 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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Magnesium sulfate	x 48 hours IV
Magnesium sulfate	Magnesium sulfate	x 48 hours IV

Primary Outcome Measures

Name	Time	Method
hours of latency to delivery	0 hours to > 168 hours	from start of study drug to delivery

Secondary Outcome Measures

Name	Time	Method
neonatal ventilator days	0 to 28 days	from delivery to 28 days of life
neonatal early onset infection	0 to 28 days	from delivery to 28 days of life
maternal postpartum length of stay	0 hours to > 168 hours	from start of study drug to delivery
maternal infection rates	0 hours to > 168 hours	from start of study drug to maternal discharge from hospital
neonatal length of stay	0 to 28 days	from delivery to 28 days of life

Trial Locations

Locations (1)

Regional Obstetrical Consultants; 🇺🇸 Chattanooga, Tennessee, United States