Magnesium Sulfate vs Placebo for Placental Abruption
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT00186069
First received: September 13, 2005
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
| Condition | Intervention |
|---|---|
|
Abruptio Placentae |
Drug: magnesium sulfate, Normal Saline |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- resolution of vaginal bleeding and contractions [ Time Frame: Treatment to resolution of symptoms ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Magnesium Sulfate |
Drug: magnesium sulfate, Normal Saline
Magnesium Sulfate or Normal Saline 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Further 2 gram boluses and rate increases up to 4 grams per hour may be administered per physician discretion.
|
| Placebo Comparator: Normal Saline |
Drug: magnesium sulfate, Normal Saline
Magnesium Sulfate or Normal Saline 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Further 2 gram boluses and rate increases up to 4 grams per hour may be administered per physician discretion.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186069
Contacts
| Contact: Iris Colon, MD | (408) 855-5550 | Iris.Colon@hhs.sccgov.org |
Locations
| 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 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Yasser Yehia El-Sayed | Stanford University |
More Information
No publications provided
| Responsible Party: | Yasser Yehia El-Sayed, Professor of Obstetrics and Gynecology, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00186069 History of Changes |
| Other Study ID Numbers: | 79811 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Abruptio Placentae Obstetric Labor Complications Pregnancy Complications Placenta Diseases Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 21, 2013