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| Name | Class |
|---|---|
| Santa Clara Valley Medical Center | OTHER |
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To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Active Comparator | Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour |
|
| Normal Saline | Placebo Comparator | Normal Saline 4 gram bolus, followed by 2 grams per hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at Delivery (Weeks) | Median gestational age at delivery (in full weeks) | Time of delivery |
| 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Y El-Sayed, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26871905 | Derived | Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnesium Sulfate | Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour 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. |
| FG001 | Normal Saline | Normal Saline 4 gram bolus, followed by 2 grams per hour 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnesium Sulfate | Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour 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. |
| BG001 | Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 48 hours after the randomization |
|
The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnesium Sulfate | Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Girsen, Manager of Research Operations | Stanford University | (650) 725-5720 | agirsen@stanford.edu |
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| ID | Term |
|---|---|
| D000037 | Abruptio Placentae |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| Normal Saline | Other | 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. |
|
|
| At 5 minutes after birth |
| Stanford |
| California |
| 94305 |
| United States |
Normal Saline 4 gram bolus, followed by 2 grams per hour 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Parity | Number of women who were nulliparous at enrollment | Number | participants |
|
| Gestational age at randomization (weeks) | Median | Full Range | weeks of gestation |
|
| Placental location | Number | participants |
|
| Vaginal bleeding before study drug administered | Number | participants |
|
|
|
|
| Secondary | Gestational Age at Delivery (Weeks) | Median gestational age at delivery (in full weeks) | Posted | Median | Full Range | weeks of gestation | 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. | Posted | Median | Full Range | Apgar score | At 5 minutes after birth |
|
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Normal Saline | Normal Saline 4 gram bolus, followed by 2 grams per hour 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. | 0 | 15 | 3 | 15 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
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| D010922 | Placenta Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |