Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population

September 17, 2009 updated by: MemorialCare

A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin

In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

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
    • California
      • Long Beach, California, United States, 92806
        • Memorial Care Center for Women/Long Beach Memorial Medical Center

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (>4 uterine contractions in 20 minutes):

    1. Cervix > 2 cm in dilation or 80% effaced
    2. Positive fetal fibronectin (if performed).
    3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria:

  • Negative fetal fibronectin
  • > 5cm dilatation
  • Multiple gestations
  • Known fetal anomalies or chromosomal abnormalities
  • Ruptured membranes
  • Significant vaginal bleeding
  • Suspected chorioamnionitis
  • Preeclampsia or uncontrolled hypertension
  • Non-reassuring fetal heart tracing
  • Placenta previa and/or accreta
  • Placenta abruption
  • Intrauterine growth restriction
  • Maternal renal disease
  • Underlying maternal cardiac condition
  • Symptomatic hyperthyroidism
  • Significant maternal disease
  • Contraindication to nifedipine or magnesium
  • Cerclage presence
  • Tocolytic use within the last 12 hours
  • Hypotension (defined as average blood pressure of <70/40's unresponsive to 1000 cc fluid bolus

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
Experimental: 1
Oral Nifedine
Drug: Nifedlipine
Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
Active Comparator: 2
Intravenous Magnesium
Drug: Magnesium
Intravenous Magnesium 6 gram load, 3 grams/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
Time Frame: At delivery
At delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
Time Frame: At Delivery
At Delivery
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
Time Frame: At delivery
At delivery
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
Time Frame: At discharge
At discharge

Collaborators and Investigators

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

Sponsor

MemorialCare

Investigators

  • Principal Investigator: Kenneth Chan, MD, Obstetrix/Memorial Care
  • Principal Investigator: Vineet K Shrivastava, MD, University of California, Irvine

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

March 1, 2008

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 464-07

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.

Subscribe