UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041520
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email eijiro.hayata@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.