Fluid Management for Cesarean Section III (FMCS-III)
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2009 | ||||
| Last Updated Date | September 8, 2009 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fluid Management for Cesarean Section III | ||||
| Official Title ICMJE | Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA) | ||||
| Brief Summary | Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Cesarean Section | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 850 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00973414 | ||||
| Other Study ID Numbers ICMJE | NJMU-09053MZ | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | XiaoFeng Shen, Nanjing Medical University | ||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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