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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2012/01/11
    • Registered Date : 2012/01/18
    • Last Updated Date : 2013/04/22
Background Information
1.Background  
CRIS Registration Number KCT0000324 
Unique Protocol ID B-0192-090-011 
Public/Brief Title Preload or coload for prevention of hypotension after spinal anesthesia for cesarean delivery 
Scientific Title Preload or coload for prevention of hypotension after spinal anesthesia for cesarean delivery  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number B-0192-090-011 
Approval Date 2012-01-12 
Institutional Review Board  
- Name Institutional Review Board of Seoul National University Bundang Hospital  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Jung-Won Hwang 
- Title Vice professor 
- Telephone  
- Affiliation Seoul National University Bundang Hospital 
- Address  
Contact Person for Public Queries
- Name Jung-Won Hwang 
- Title Vice professor 
- Telephone  
- Affiliation Seoul National University Bundang Hospital 
- Address  
Contact Person for Updating Information
- Name Ah-Young Oh 
- Title Assistant Professor 
- Telephone  
- Affiliation Seoul National University Bundang Hospital 
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2012-01-12 , Actual
Target Number of Participant 80
Primary Completion Date 2012-08-20
Study Completion Date 2013-02-19
Recruitment Status by Participating Study Site 1 
- Name of Study Site Seoul National University Bundang Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2012-01-12 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Seoul National University Bundang Hospital 
- Organization Type Medical Institute  
- Project ID B-0192-090-011 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Seoul National University Bundang Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Spinal anesthesia for C/S frequently results in hypotension due to sympathetic block and vasodilation.Volume loading is necessary for the prevention of hypotension and crystalloid is used frequently because it is less expansive and induces less anaphylaxis. However, the duration of crystalloids remaining in vessel is short and the question remains if it could prevent hypotension after spinal anesthesia. In this study, we evaluated and compared the effect of preload and coload of crystalloid solution during spinal anesthesia for Cesarean section  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Prevention
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description groupA: rapid infusion of 15 cc/kg Hartmann's solution after intrathecal injection of local anesthetic
groupB: infusion of 15cc/kc Hartmann's solution after arrival in the delivery room before intrathecal injection of local anesthetic  
Number of Arms
Arm 1 Arm Label groupA 
Target Number of Participant 40 
Arm Type Experimental 
Arm Description groupA: rapid infusion of 15 cc/kg Hartmann's solution after intrathecal injection of local anesthetic  
Arm 2 Arm Label groupB 
Target Number of Participant 40 
Arm Type Active comparator 
Arm Description groupB: infusion of 15cc/kc Hartmann's solution after arrival in the delivery room before intrathecal injection of local anesthetic  
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Pregnancy, childbirth and the puerperium
 
Rare Disease No
Inclusion
Criteria
Gender Female 
Age No Limit ~ No Limit
Description parturient undergoing cesarean section under spinal anesthesia  
Exclusion Criteria preeclampsia, cardiac disease, preterm delivery(<37 wks), multiple pregnancy, fetal distress  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome systolic blood pressure 
- Timepoint every 1 min until 15 min after the spinal injection of local anesthetic 
Primary Outcome(s) 2 
- Outcome heart rate 
- Timepoint every 1 min until 15 min after the spinal injection of local anesthetic 
Secondary Outcome(s) 1 
- Outcome the dose of ephedrine administered 
- Timepoint until 15 min after the spinal injection of local anesthetic 
Secondary Outcome(s) 2 
- Outcome nausea 
- Timepoint until 15 min after the spinal injection of local anesthetic 
Secondary Outcome(s) 3 
- Outcome Apgar score of the neonate 
- Timepoint 1 min, 5 min after delivery 
Secondary Outcome(s) 4 
- Outcome cord blood gas analysis (arterial and venous) 
- Timepoint immediately after delivery 
Secondary Outcome(s) 5 
- Outcome the level of anesthesia 
- Timepoint every 1 min from 3 min after intrathecal injection, until 15 min  
Secondary Outcome(s) 6 
- Outcome vomiting 
- Timepoint until 15 min after the spinal injection of local anesthetic 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration