UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040395 |
|---|---|
| Receipt number | R000046093 |
| Scientific Title | A retrospective study to construct a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate |
| Date of disclosure of the study information | 2020/05/14 |
| Last modified on | 2020/05/13 23:31:16 |
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Basic information
Public title
A retrospective study to construct a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate
Acronym
A retrospective study to construct a scoring system for predicting neonatal acidemia
Scientific Title
A retrospective study to construct a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate
Scientific Title:Acronym
A retrospective study to construct a scoring system for predicting neonatal acidemia
Region
| Japan |
Condition
Condition
vaginal deliveries
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to propose a medical indicator during labor by constructing a scoring system using 5-tier classification of fetal heart rate pattern.
Basic objectives2
Others
Basic objectives -Others
Relationship between the score and umbilical artery pH
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical analysis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
normal vaginal deliveries
Key exclusion criteria
caesarean deliveries, multiple pregnancy, preterm births, stillbirth, fetal growth restriction, fetal anomaly, fetal chromosomal abnormality
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Eijiro |
| Middle name | |
| Last name | Hayata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1, Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
eijiro.hayata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Ito |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1, Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
ayumu.itou@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University Omori Medical Center
Address
6-11-1, Omorinishi, Ota-ku, Tokyo, Japan
Tel
03-3762-4151
omori.rinri@ext.toho-u.ac.jp
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
| 2020 | Year | 05 | Month | 14 | 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
484
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046093
