Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

October 2, 2018 updated by: Yasser Yehia El-Sayed, Stanford University
To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

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
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

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
Preterm labor treatment with Magnesium Sulfate.
Drug: Magnesium Sulfate
Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
Active Comparator: Nifedipine
Preterm labor treatment with Nifedipine.
Drug: Nifedipine
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Time Frame: 48 hours after administration of study medication.
Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.
48 hours after administration of study medication.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Uterine Quiescence
Time Frame: Until delivery, up to 42 weeks of gestation
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Until delivery, up to 42 weeks of gestation
Gestational Age at Delivery
Time Frame: Until delivery, up to 42 weeks of gestation
Presented as weeks
Until delivery, up to 42 weeks of gestation
Neonatal Birth Weight
Time Frame: Until delivery, up to 42 weeks of gestation
Presented as grams
Until delivery, up to 42 weeks of gestation
Serious Maternal Adverse Effect
Time Frame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Composite Neonatal Morbidity
Time Frame: From delivery until discharge from the hospital, up to 30 days of age
Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
From delivery until discharge from the hospital, up to 30 days of age

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Yasser Yehia El-Sayed, Stanford University

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

Helpful Links

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, 1999

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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