UMIN-CTR Clinical Trial

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