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Magnesium Sulfate vs Placebo for Placental Abruption

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ClinicalTrials.gov Identifier: NCT00186069
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 20, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

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

Condition or disease Intervention/treatment Phase
Abruptio Placentae Drug: Magnesium Sulfate Other: Normal Saline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
Study Start Date : March 2004
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gestational Age at Delivery (Weeks) [ Time Frame: Time of delivery ]
    Median gestational age at delivery (in full weeks)

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186069


Locations
United States, California
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
Investigators
Principal Investigator: Yasser Y El-Sayed, MD Stanford University

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
First Posted: September 16, 2005    Key Record Dates
Results First Posted: April 20, 2017
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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