Back to resultsMagnesium Sulfate vs Placebo for Placental Abruption
Primary Purpose
Abruptio Placentae
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Abruptio Placentae
Eligibility 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
Sites / Locations
- Santa Clara Valley Medical Center
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium Sulfate
Normal Saline
Arm Description
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Normal Saline 4 gram bolus, followed by 2 grams per hour
Outcomes
Primary Outcome Measures
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
Secondary Outcome Measures
Gestational Age at Delivery (Weeks)
Median gestational age at delivery (in full weeks)
Neonatal Apgar Score at 5 Minutes
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.
Full Information
NCT ID
NCT00186069
First Posted
September 13, 2005
Last Updated
December 1, 2017
Sponsor
Stanford University
Collaborators
Santa Clara Valley Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00186069
Brief Title
Magnesium Sulfate vs Placebo for Placental Abruption
Official Title
Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Santa Clara Valley Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abruptio Placentae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Sulfate
Arm Type
Active Comparator
Arm Description
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal Saline 4 gram bolus, followed by 2 grams per hour
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Active study drug
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Normal Saline infusion as placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
Description
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
Time Frame
48 hours after the randomization
Secondary Outcome Measure Information:
Title
Gestational Age at Delivery (Weeks)
Description
Median gestational age at delivery (in full weeks)
Time Frame
Time of delivery
Title
Neonatal Apgar Score at 5 Minutes
Description
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.
Time Frame
At 5 minutes after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Y El-Sayed, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26871905
Citation
Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.
Results Reference
derived
Learn more about this trial
Magnesium Sulfate vs Placebo for Placental Abruption
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