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

This study is currently recruiting participants.

Verified by Stanford University, June 2009

First Received: September 13, 2005 Last Updated: June 17, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment
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

Secondary Outcome Measures:

preterm delivery
neonatal outcomes

Estimated Enrollment:	48
Study Start Date:	March 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

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:	Stanford University School of Medicine ( Yasser Yehia El-Sayed, a Principal Investigator at Stanford )
Study ID Numbers:	79811
Study First Received:	September 13, 2005
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00186069 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pregnancy Complications
Abruptio Placentae
Magnesium Sulfate
Obstetric Labor Complications
Anesthetics
Central Nervous System Depressants
Calcium Channel Blockers

Cardiovascular Agents
Calcium, Dietary
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anticonvulsants

Additional relevant MeSH terms:

Placenta Diseases
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Abruptio Placentae
Magnesium Sulfate
Physiological Effects of Drugs
Obstetric Labor Complications
Calcium Channel Blockers
Central Nervous System Depressants
Anesthetics
Reproductive Control Agents

Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009