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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name