UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036454
Receipt number R000041545
Scientific Title Accuracy of pH test paper for cerebrospinal fluid during spinal anesthesia : prospective study in healthy pregnant women under scheduled caesarean section
Date of disclosure of the study information 2019/05/01
Last modified on 2019/10/10 14:10:15

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Basic information

Public title

Accuracy of pH test paper for cerebrospinal fluid during spinal anesthesia
: prospective study in healthy pregnant women under scheduled caesarean section

Acronym

cerebrospinal fluid pH test paper survey

Scientific Title

Accuracy of pH test paper for cerebrospinal fluid during spinal anesthesia
: prospective study in healthy pregnant women under scheduled caesarean section

Scientific Title:Acronym

cerebrospinal fluid pH test paper survey

Region

Japan


Condition

Condition

healthy pregnant women under scheduled caesarean section

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measure cerebrospinal fluid pH and examine correlation with pH on pH paper

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebrospinal fluid pH value

Key secondary outcomes

pH value on the pH test paper


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

healthy pregnant women under scheduled caesarean section

Key exclusion criteria

Serious respiratory illness
Serious metabolic acidosis
Patients with cerebrospinal disorders
Patients who are not eligible for spinal anesthesia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshie
Middle name
Last name Toba

Organization

Seirei hamamatsu general hospital

Division name

Anesthesiology

Zip code

430

Address

Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City, Shizuoka prefecture

TEL

053-474-2222

Email

yoshtoba@sis.seirei.or.jp


Public contact

Name of contact person

1st name Hiromi
Middle name
Last name Ikegami

Organization

Seirei hamamatsu general hospital

Division name

Anesthesiology

Zip code

430

Address

Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City, Shizuoka prefecture

TEL

053-474-2222

Homepage URL


Email

hi-ikegami@sis.seirei.or.jp


Sponsor or person

Institute

Seirei hamamatsu general hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seirei hamamatsu general hospital

Address

Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City, Shizuoka prefecture

Tel

053-474-2222

Email

m-kimata@sis.seirei.or.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Completed

Date of protocol fixation

2019 Year 05 Month 01 Day

Date of IRB

2009 Year 04 Month 17 Day

Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2019 Year 04 Month 09 Day

Last modified on

2019 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041545


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name