Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

NCT ID: NCT00463736

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-03-31

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.

Conditions

Preterm Premature Rupture of Membranes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magnesium sulfate

x 48 hours IV

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type: DRUG

Normal saline

x 48 hours IV

Group Type: PLACEBO_COMPARATOR

Magnesium sulfate

Intervention Type: DRUG

Interventions

Magnesium sulfate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Obstetrical Consultants

OTHER

Sponsor Role: lead

Responsible Party

Lorrie Mason

Christian Briery MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian M Briery, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department

Locations

Regional Obstetrical Consultants

Chattanooga, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35947046 (View on PubMed)

Other Identifiers

07-006

Identifier Type: -

Identifier Source: org_study_id