UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between total hemoglobin index measured using finger-mounted tissue oximetry and blood hemoglobin levels during puerperium: a prospective study
Title of the study (Brief title)	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	Toshiyuki Uchida
Organization	Hamamatsu University School of Medicine
Division name	Department of Obstetrics and Gynecology
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	Kenta Kawai
Organization	Hamamatsu University School of Medicine
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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