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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 17, 2009

Start Date ^ICMJE

March 2004

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

resolution of vaginal bleeding and contractions

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00186069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

preterm delivery
neonatal outcomes

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment

Condition ^ICMJE

Abruptio Placentae

Intervention ^ICMJE

Drug: magnesium sulfate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Iris Colon, MD

(408) 855-5550

Iris.Colon@hhs.sccgov.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00186069

Responsible Party

Yasser Yehia El-Sayed, a Principal Investigator at Stanford, Stanford University School of Medicine

Study ID Numbers ^ICMJE

79811

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yasser Yehia El-Sayed

Stanford University

Information Provided By

Stanford University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP