UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041520 |
|---|---|
| Receipt number | R000047402 |
| Scientific Title | A prospective observational study on the usefulness of a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/09/05 10:30:52 |
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Basic information
Public title
A prospective observational study on the usefulness of a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate
Acronym
A prospective observational study on the usefulness of a scoring system for predicting neonatal acidemia
Scientific Title
A prospective observational study on the usefulness of a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate
Scientific Title:Acronym
A prospective observational study on the usefulness of 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
We conducted "A retrospective study to construct a scoring system for predicting neonatal acidemia using 5-tier classification of fetal heart rate"(UMIN000040395) as a preliminary study. We have found our new scoring system (Integrated score index to predict fetal acidemia: iPREFACE score) could be the candidate for predicting fetal acidemia during the second stage of labor. The purpose of this study is to verify the usefulness and validity of the iPREFACE score by evaluating its relationship the course of pregnancy/delivery and the outcome of the newborns.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neonatal mortality
Key secondary outcomes
Neonatal morbidity
Neonatal hospitalization rate and length of hospital stay
Short-term development of the newborn
Apgar score
Umbilical artery blood gas analysis values collected immediately after birth
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
Patients scheduled for full-term normal vaginal delivery
Key exclusion criteria
Elective caesarean section
Multiple pregnancy
Preterm birth
Stillbirth
Fetal anomaly
Fetal chromosomal abnormality
The cases could not monitored for 30 minutes before deliveries
The cases could not be accurately monitored
The cases could not be sampled umbilical artery blood
Target sample size
1000
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 | 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
Homepage URL
eijiro.hayata@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 | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CTG findings for approximately 30 minutes during the second stage of labour until delivery were used for scoring. All decelerations, except prolonged deceleration, were evaluated at the level of the 5-tier classification, and the sum of all numbers of these levels was calculated as the score. Prolonged deceleration was defined as a multiplication of the duration (minutes) by the number of the level on the 5-tier classification. The durations (minutes) were expressed as whole numbers.
Management information
Registered date
| 2020 | Year | 08 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047402
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
