Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

August 17, 2016 updated by: Lorrie Mason, Regional Obstetrical Consultants

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Regional Obstetrical Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium sulfate
x 48 hours IV
Drug: Magnesium sulfate
Placebo Comparator: Normal saline
x 48 hours IV
Drug: Magnesium sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hours of latency to delivery
Time Frame: 0 hours to > 168 hours
from start of study drug to delivery
0 hours to > 168 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal postpartum length of stay
Time Frame: 0 hours to > 168 hours
from start of study drug to delivery
0 hours to > 168 hours
maternal infection rates
Time Frame: 0 hours to > 168 hours
from start of study drug to maternal discharge from hospital
0 hours to > 168 hours
neonatal ventilator days
Time Frame: 0 to 28 days
from delivery to 28 days of life
0 to 28 days
neonatal early onset infection
Time Frame: 0 to 28 days
from delivery to 28 days of life
0 to 28 days
neonatal length of stay
Time Frame: 0 to 28 days
from delivery to 28 days of life
0 to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Obstetrical Consultants

Investigators

  • Principal Investigator: Christian M Briery, MD, Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Premature Rupture of Membranes

Clinical Trials on Magnesium sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe