Magnesium Sulfate vs Placebo for Placental Abruption
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|ClinicalTrials.gov Identifier: NCT00186069|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 20, 2017
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Abruptio Placentae||Drug: Magnesium Sulfate Other: Normal Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||November 2017|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Yasser Y El-Sayed, MD||Stanford University|