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The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colloid, then phenylephrine infusion | Experimental | colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
|
| crystalloid, then phenylephrine infusion | Active Comparator | crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colloid administration | Other | The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Maternal Hypotension | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of Phenylephrine Used | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby | |
| Incidence of Maternal Bradycardia | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PennState Hershey Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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We applied for an IRB approval for 90 patients. The power analysis indicated that a minimum of 37 subjects for each group was needed. To allow for potential dropouts, we applied for 45 patient in each group. (total of 9O patients)
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| ID | Title | Description |
|---|---|---|
| FG000 | Colloid, Then Phenylephrine Infusion | colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
| FG001 | Crystalloid, Then Phenylephrine Infusion | Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Colloid, Then Phenylephrine Infusion | colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Maternal Hypotension | Posted | Number | percentage of participants | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
|
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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 | Colloid, Then Phenylephrine Infusion | colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
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technical problems for analysing fetal pH in all newborns
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonia Vaida | Penn State Milton S. Hershey Medical Center | 7175318433 | svaida@hmc.psu.edu |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Crystalloid administration | Other | The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. |
|
| phenylephrine infusion | Drug | A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
|
| Fetal Cord Blood pH | delivery of the baby |
| APGAR Scores | The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). | Apgar scores were assessed at 1 amd 5 min after delivery of the baby |
| Incidence of Maternal Nausea and Vomiting | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
| Crystalloid, Then Phenylephrine Infusion |
Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Dosage of Phenylephrine Used | Posted | Mean | Standard Deviation | mcg of phenylephrine | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
|
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| Secondary | Incidence of Maternal Bradycardia | Posted | Number | percentage of participants | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
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| Secondary | Fetal Cord Blood pH | Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure. | Posted | delivery of the baby |
|
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| Secondary | APGAR Scores | The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). | Posted | Median | Full Range | units on a scale | Apgar scores were assessed at 1 amd 5 min after delivery of the baby |
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| Secondary | Incidence of Maternal Nausea and Vomiting | Posted | Number | percentage of participants | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Crystalloid, Then Phenylephrine Infusion | Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. | 0 | 41 | 0 | 41 |
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