UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020738 |
|---|---|
| Receipt number | 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 09:00:36 |
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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
| Obstetrics 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
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
utty@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023928
