Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

Preterm Premature Rupture of Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00463736
• Other study ID #: 07-006
• Status: Terminated
• Phase: N/A
• First received: April 19, 2007
• Last updated: August 17, 2016
• Start date: April 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2016
• Source: Regional Obstetrical Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membranes
• Rupture

Intervention

Drug:
• Magnesium sulfate

Locations

Country	Name	City	State
United States	Regional Obstetrical Consultants	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Regional Obstetrical Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hours of latency to delivery	from start of study drug to delivery	0 hours to > 168 hours	No
Secondary	maternal postpartum length of stay	from start of study drug to delivery	0 hours to > 168 hours	No
Secondary	maternal infection rates	from start of study drug to maternal discharge from hospital	0 hours to > 168 hours	No
Secondary	neonatal ventilator days	from delivery to 28 days of life	0 to 28 days	No
Secondary	neonatal early onset infection	from delivery to 28 days of life	0 to 28 days	No
Secondary	neonatal length of stay	from delivery to 28 days of life	0 to 28 days	No