Magnesium Sulfate vs Placebo for Placental Abruption

Abruptio Placentae Clinical Trial

Official title:

Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186069
• Other study ID #: 79811
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 1, 2017
• Start date: March 2004
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abruptio Placentae

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Santa Clara Valley Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours after the randomization
Secondary	Gestational Age at Delivery (Weeks)	Median gestational age at delivery (in full weeks)	Time of delivery
Secondary	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.	At 5 minutes after birth