Clinical trial NCT00463736: Magnesium Sulfate Versus Placebo for Tocolysis in PPROM
Official title: Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Premature Rupture of Membranes
Keywords: short term tocolysis
preterm premature rupture of membranes
Lead sponsor: Regional Obstetrical Consultants
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: hours of latency to delivery
timeFrame: 0 hours to > 168 hours
Secondary outcomes:
measure: maternal postpartum length of stay
timeFrame: 0 hours to > 168 hours
measure: maternal infection rates
timeFrame: 0 hours to > 168 hours
measure: neonatal ventilator days
timeFrame: 0 to 28 days
measure: neonatal early onset infection
timeFrame: 0 to 28 days
measure: neonatal length of stay
timeFrame: 0 to 28 days
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
Study officials:
affiliation: Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
name: Christian M Briery, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.