This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Magnesium Sulfate vs Placebo for Placental Abruption

This study is ongoing, but not recruiting participants.
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University Identifier:
First received: September 13, 2005
Last updated: March 9, 2017
Last verified: March 2017
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

Condition Intervention
Abruptio Placentae Drug: Magnesium Sulfate Other: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption

Resource links provided by NLM:

Further study details as provided by Yasser Yehia El-Sayed, Stanford University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Gestational Age at Delivery (Weeks) [ Time Frame: Time of delivery ]
    Median gestational age at delivery (in full weeks)

  • Neonatal Apgar Score at 5 Minutes [ Time Frame: 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.

Enrollment: 30
Study Start Date: March 2004
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00186069

United States, California
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
Principal Investigator: Yasser Y El-Sayed, MD Stanford University
  More Information

Responsible Party: Yasser Yehia El-Sayed, Professor of Obstetrics and Gynecology, Stanford University Identifier: NCT00186069     History of Changes
Other Study ID Numbers: 79811
Study First Received: September 13, 2005
Results First Received: October 12, 2016
Last Updated: March 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Abruptio Placentae
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents processed this record on August 22, 2017