Magnesium Sulfate vs Placebo for Placental Abruption
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
|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|
- resolution of vaginal bleeding and contractions [ Time Frame: Treatment to resolution of symptoms ] [ Designated as safety issue: No ]
- 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 ]
|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)|
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
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.
|Contact: Iris Colon, MD||(408) 855-5550||Iris.Colon@hhs.sccgov.org|
|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|
|Principal Investigator:||Yasser Yehia El-Sayed||Stanford University|