UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028866
Receipt No. R000033023
Scientific Title Association between total hemoglobin index measured using finger-mounted tissue oximetry and blood hemoglobin levels during puerperium: a prospective study
Date of disclosure of the study information 2017/08/28
Last modified on 2017/08/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Association between total hemoglobin index measured using finger-mounted tissue oximetry and blood hemoglobin levels during puerperium: a prospective study
Acronym Association between total hemoglobin index and blood hemoglobin levels during puerperium
Scientific Title Association between total hemoglobin index measured using finger-mounted tissue oximetry and blood hemoglobin levels during puerperium: a prospective study
Scientific Title:Acronym Association between total hemoglobin index and blood hemoglobin levels during puerperium
Region
Japan

Condition
Condition Puerperium
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between the total hemoglobin index measured using finger-mounted tissue oximetry and blood hemoglobin levels during puerperium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To calculate the correlation coefficient between the total hemoglobin index measured using finger-mounted tissue oximetry at the thenar muscle and blood hemoglobin levels during puerperium.
Key secondary outcomes To calculate the correlation coefficient between the total hemoglobin index measured using finger-mounted tissue oximetry at deltoid and sternocleidomastoid muscles and blood hemoglobin levels during puerperium.
As an exploratory research, to investigate intra- and inter-rater reliabilities, a time-dependent change in values at the same objectives, and the association between tissue oxygen saturation and blood hemoglobin levels.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Finger-mounted tissue oximetry
For one day or two days
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 1. Women who are aged >19 years
2. Women who delivered in the past week, excluding the day of delivery
3. Women who have voluntarily provided written consent for participating in this study
4. Women whose hemoglobin levels were or will be measured along with hematological examination on the day of the study
Key exclusion criteria 1. Women who have malfunction in the circulatory and/or respiratory system: systolic blood pressure < 90 mmHg; pulse rate > 120/min; administration of a vasopressor; percutaneous oxygen saturation < 95%; administration of oxygen; presence of local circulatory dysfunction; active bleeding; and active diseases, such as acute heart failure and bronchial asthma
2. Body temperature > 38.0 degrees Celsius, body temperature < 35.0 degrees Celsius, and white blood cell count > 15000/mm3 or < 2000/mm3
3. Abnormal indoor condition or ambient temperature: ambient temperature > 30.0 degrees Celsius, ambient temperature < 10.0 degrees Celsius, or an abnormal weather
4. The interval between the measurement of the total hemoglobin index and hematological examination of >12 h
5. Women who have undergone transfusion in the past 16 weeks
6. A history of abnormal hemoglobinopathy
7. A body mass index of >30 or <18.5
8. Women who are evaluated to be ineligible for participating in the study by doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Uchida
Organization Hamamatsu University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2309
Email utty@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Kawai
Organization Hamamatsu University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2309
Homepage URL
Email D15018@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 28 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 28 Day
Last modified on
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.