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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020738
Receipt No. R000023928
Scientific Title Development of a new intrapartum fetal monitoring technique using a finger-mounted fetal tissue oximeter: a multicenter study
Date of disclosure of the study information 2016/02/03
Last modified on 2018/05/26

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Basic information
Public title Development of a new intrapartum fetal monitoring technique using a finger-mounted fetal tissue oximeter: a multicenter study
Acronym Development of a finger-mounted fetal tissue oximeter
Scientific Title Development of a new intrapartum fetal monitoring technique using a finger-mounted fetal tissue oximeter: a multicenter study
Scientific Title:Acronym Development of a finger-mounted fetal tissue oximeter
Region
Japan

Condition
Condition Pregnant women over 36 weeks of gestation and who will undergo transvaginal delivery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of the examiner's finger-mounted fetal tissue oximeter for fetal monitoring in pregnant women during intrapartum.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To establish standard values for fetal tissue oxygen saturation and total hemoglobin index during the first and second stages of labor and the newborn's tissue oxygen saturation and total hemoglobin index after birth.
Key secondary outcomes 1. Incidence of abnormal fetal heart rate monitoring in newborns whose umbilical cord artery blood pH is >7.25 and the Apgar score is >8.
2. Incidence of normal fetal tissue oxygen saturation and total hemoglobin index in patients who fulfill a key secondary outcome of 1.
3. Incidence of normal fetal heart rate monitoring in newborns whose umbilical cord artery blood pH is <7.25 and the Apgar score is <8.
4. Incidence of abnormal fetal tissue oxygen saturation and total hemoglobin index in patients who fulfill a key secondary outcome of 3.
5. Fetal tissue oxygen saturation and total hemoglobin index in patients with abnormal fetal heart rate.

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 fetal tissue oximeter
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 1. Pregnant women over 36 weeks of gestation and who will undergo transvaginal delivery.
2. Patients who have voluntarily provided written consent to participate in this trial, after having been thoroughly briefed and informed of the nature of the trial [if the patient is <20 years old, written consent must be obtained from the husband (>20 years) or a parent].
Key exclusion criteria 1. Multiple pregnancies
2. Previously underwent myomectomy and/or cesarean section
3. Fetal malpresentation
4. Malposition of the placenta
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiro Kanayama
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 kanayama@hama-md.ac.jp

Public contact
Name of contact person
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
Homepage URL
Email utty@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 02 Month 03 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 06 Month 16 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 26 Day
Last modified on
2018 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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