Magnesium Sulfate vs Placebo for Placental Abruption

Not Applicable

Completed

• Conditions: Abruptio Placentae
• Interventions: Drug: Magnesium Sulfate; Other: Normal Saline

• Registration Number: NCT00186069
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2014-06
• Results First Submitted: 2016-10-12
• Results First Submitted QC: 2017-03-09
• Results First Posted: 2017-04-20
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate	Magnesium Sulfate	Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Normal Saline	Normal Saline	Normal Saline 4 gram bolus, followed by 2 grams per hour

Primary Outcome Measures

Name	Time	Method
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours	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

Name	Time	Method
Neonatal Apgar Score at 5 Minutes	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.
Gestational Age at Delivery (Weeks)	Time of delivery	Median gestational age at delivery (in full weeks)

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States