Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
Overview
- Phase
- Not Applicable
- Intervention
- Magnesium Sulfate
- Conditions
- Abruptio Placentae
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Yasser Yehia El-Sayed
Professor of Obstetrics and Gynecology
Stanford University
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
Arms & Interventions
Magnesium Sulfate
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Intervention: Magnesium Sulfate
Normal Saline
Normal Saline 4 gram bolus, followed by 2 grams per hour
Intervention: Normal Saline
Outcomes
Primary Outcomes
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 Outcomes
- Neonatal Apgar Score at 5 Minutes(At 5 minutes after birth)
- Gestational Age at Delivery (Weeks)(Time of delivery)