Magnesium Sulfate vs Placebo for Placental Abruption - Full Text View

Sponsor:	Stanford University
Information provided by (Responsible Party):	Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:	NCT00186069

Purpose

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

Condition	Intervention
Abruptio Placentae	Drug: magnesium sulfate, Normal Saline

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption

Resource links provided by NLM:

Drug Information available for: Magnesium sulfate Magnesium

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

resolution of vaginal bleeding and contractions [ Time Frame: Treatment to resolution of symptoms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

preterm delivery [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
neonatal outcomes [ Time Frame: time of delivery to time of discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2004
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Magnesium Sulfate	Drug: magnesium sulfate, Normal Saline Magnesium Sulfate or Normal Saline 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Further 2 gram boluses and rate increases up to 4 grams per hour may be administered per physician discretion.
Placebo Comparator: Normal Saline	Drug: magnesium sulfate, Normal Saline Magnesium Sulfate or Normal Saline 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Further 2 gram boluses and rate increases up to 4 grams per hour may be administered per physician discretion.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186069

Contacts

Contact: Iris Colon, MD

(408) 855-5550

Iris.Colon@hhs.sccgov.org

Locations

United States, California
Santa Clara Valley Medical Center	Recruiting
San Jose, California, United States, 95128
Contact: Iris Colon, MD 408-855-5550 Iris.Colon@hhs.sccgov.org
Sub-Investigator: Iris Colon
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Yasser Y El-Sayed, MD 650-723-3198 yasser.el-sayed@stanford.edu
Principal Investigator: Yasser Yehia El-Sayed

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Yasser Yehia El-Sayed

Stanford University

More Information

No publications provided

Responsible Party:	Yasser Yehia El-Sayed, Professor of Obstetrics and Gynecology, Stanford University
ClinicalTrials.gov Identifier:	NCT00186069 History of Changes
Other Study ID Numbers:	79811
Study First Received:	September 13, 2005
Last Updated:	September 15, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Abruptio Placentae
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 13, 2012