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To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Active Comparator | Preterm labor treatment with Magnesium Sulfate. |
|
| Nifedipine | Active Comparator | Preterm labor treatment with Nifedipine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation. | 48 hours after administration of study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Uterine Quiescence | Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change. | Until delivery, up to 42 weeks of gestation |
| Gestational Age at Delivery |
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Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Yehia El-Sayed | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17601897 | Result | Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35. | |
| 35947046 | Derived | Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. |
| Label | URL |
|---|---|
| Obstet Gynecol. 2007 Jul;110(1):61-7. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnesium Sulfate | Preterm labor treatment with Magnesium Sulfate. Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. |
| FG001 | Nifedipine | Preterm labor treatment with Nifedipine. Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnesium Sulfate | Preterm labor treatment with Magnesium Sulfate. Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. |
| BG001 |
| 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 | Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation. | Posted | Count of Participants | Participants | 48 hours after administration of study medication. |
|
From study enrollment until discharge from the delivery hospital, up to 30 days after delivery.
Adverse events were assessed by patient interview from a list of adverse effects and chart review.
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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 | Preterm labor treatment with Magnesium Sulfate. Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Girsen | Stanford University | (650) 725-5720 | agirsen@stanford.edu |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| 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 |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Nifedipine | Drug | Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours. |
|
Presented as weeks
| Until delivery, up to 42 weeks of gestation |
| Neonatal Birth Weight | Presented as grams | Until delivery, up to 42 weeks of gestation |
| Serious Maternal Adverse Effect | A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension. | From study enrollment until discharge from delivery hospital, up to 30 days after delivery. |
| Composite Neonatal Morbidity | Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death. | From delivery until discharge from the hospital, up to 30 days of age |
| Nifedipine |
Preterm labor treatment with Nifedipine. Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Preterm labor treatment with Nifedipine.
Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
|
|
|
| Secondary | Time to Uterine Quiescence | Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change. | Posted | Mean | Standard Deviation | hours | Until delivery, up to 42 weeks of gestation |
|
|
|
| Secondary | Gestational Age at Delivery | Presented as weeks | Posted | Mean | Standard Deviation | weeks | Until delivery, up to 42 weeks of gestation |
|
|
|
| Secondary | Neonatal Birth Weight | Presented as grams | Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | grams | Until delivery, up to 42 weeks of gestation |
|
|
|
| Secondary | Serious Maternal Adverse Effect | A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension. | Posted | Count of Participants | Participants | From study enrollment until discharge from delivery hospital, up to 30 days after delivery. |
|
|
|
| Secondary | Composite Neonatal Morbidity | Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death. | Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed. | Posted | Count of Participants | Participants | From delivery until discharge from the hospital, up to 30 days of age |
|
|
|
| 0 |
| 92 |
| 25 |
| 92 |
| 29 |
| 92 |
| EG001 | Nifedipine | Preterm labor treatment with Nifedipine. Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours. | 0 | 100 | 12 | 100 | 22 | 100 |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Double vision | Eye disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
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| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |