Magnesium Sulfate vs Placebo for Placental Abruption

December 1, 2017 updated by: Yasser Yehia El-Sayed, Stanford University

Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption

To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Study Type

Interventional

Enrollment (Actual)

30

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
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
      • 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:

- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.

Exclusion Criteria:

- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium Sulfate
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Drug: Magnesium Sulfate
Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.
Other Names:
  • Active study drug
Placebo Comparator: Normal Saline
Normal Saline 4 gram bolus, followed by 2 grams per hour
Other: Normal Saline
Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.
Other Names:
  • Normal Saline infusion as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
Time Frame: 48 hours after the randomization
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
48 hours after the randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Age at Delivery (Weeks)
Time Frame: Time of delivery
Median gestational age at delivery (in full weeks)
Time of delivery
Neonatal Apgar Score at 5 Minutes
Time Frame: At 5 minutes after birth
The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.
At 5 minutes after birth

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

Santa Clara Valley Medical Center

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, 2004

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79811

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.

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