UMIN-CTR Clinical Trial

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

Puerperium

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

28

Day

Last modified on

2017

Year

08

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033023