UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020560 |
|---|---|
| Receipt number | R000023739 |
| Scientific Title | The retrospective study of perioperative fluid management for preeclamptic parturient in Cesarean section under spinal anesthesia |
| Date of disclosure of the study information | 2016/01/17 |
| Last modified on | 2016/07/14 12:41:09 |
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Basic information
Public title
The retrospective study of perioperative fluid management for preeclamptic parturient in Cesarean section under spinal anesthesia
Acronym
The retrospective study of perioperative fluid management for preeclamptic parturient
Scientific Title
The retrospective study of perioperative fluid management for preeclamptic parturient in Cesarean section under spinal anesthesia
Scientific Title:Acronym
The retrospective study of perioperative fluid management for preeclamptic parturient
Region
| Japan |
Condition
Condition
preeclampsia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to search adequate fluid management for preeclamptic parturient in Cesarean section under spina anesthesia preventing supine hypotension syndrome. We evaluate extracellular fluid volume using biophysical electrical impedance method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In Cesarean section under spinal anesthesia:
maternal blood pressure, heart rate, the incidence of hypotension, dose of vasopressor, fluid infusion volume, urinie output, extracellular fluid volume (R0 or Re) measured with biophysical electrical impedance method, APGAR score, UApH
Key secondary outcomes
The hemodynamic parameter and R0 was measured every 1 minute until baby delivery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Parturient received Cesarean section under spinal anesthesia
Key exclusion criteria
Contraindication of spinal anesthesia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MUNETAKA HIROSE |
Organization
Hyogo College of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1 Mukogawacho Nishinomiya Hyogo
TEL
0798-45-6392
mhirose@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NOBUTAKA KARIYA |
Organization
Hyogo College of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1 Mukogawacho Nishinomiya Hyogo
TEL
0798-45-6392
Homepage URL
nkariya@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫医科大学(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The hemodynamic parameter and extracellular fluid volume (R0)
Management information
Registered date
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2016 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023739
