UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039490
Receipt number R000045029
Scientific Title Intercristal line determined by palpation in sitting and lateral position for obstetric patients: a prospective observational study
Date of disclosure of the study information 2020/02/17
Last modified on 2022/02/02 10:25:50

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Basic information

Public title

Intercristal line determined by palpation in sitting and lateral position for obstetric patients: a prospective observational study

Acronym

Intercristal line determined by palpation in sitting and lateral position for obstetric patients: a prospective observational study

Scientific Title

Intercristal line determined by palpation in sitting and lateral position for obstetric patients: a prospective observational study

Scientific Title:Acronym

Intercristal line determined by palpation in sitting and lateral position for obstetric patients: a prospective observational study

Region

Japan


Condition

Condition

obstetric patients

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate intercristal line determined by palpation in sitting and lateral position for obstetric patients.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The segment through which intercristal line determined by palpation passes

Key secondary outcomes



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

obstetric patients

Key exclusion criteria

1) Past history of spine surgery
2) Scoliosis

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Kamimura

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

TEL

052-851-5511

Email

ez4pixy1118@gmail.com


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Kamimura

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

TEL

052-851-5511

Homepage URL


Email

ez4pixy1118@gmail.com


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Management Center, Nagoya City University Hospital

Address

1Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

Tel

052-858-7215

Email

clinical_research@med.nagoya-cu.ac.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

2020 Year 02 Month 17 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

40

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

waiting for publication

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

2020 Year 03 Month 01 Day

Date of IRB

2020 Year 03 Month 20 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2020 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 01 Month 31 Day


Other

Other related information

The segment through which intercristal line determined by palpation passes, and patients date(height, weight, BMI, age, gestational age)


Management information

Registered date

2020 Year 02 Month 15 Day

Last modified on

2022 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name