Magnesium Sulfate vs Placebo for Placental Abruption

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT00186069
First received: September 13, 2005
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Abruptio Placentae
Drug: Magnesium Sulfate
Other: 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:


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 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Normal Saline infusion as placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Active, not recruiting
Stanford, California, United States, 94305
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: June 13, 2013
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 July 20, 2014