UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045098
Receipt number R000051512
Scientific Title Interpretation of cardiotocogram with stress hormones andtiming of intervention at delivery and neonatal prognosis
Date of disclosure of the study information 2021/08/22
Last modified on 2021/08/09 10:00:29

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Basic information

Public title

Interpretation of cardiotocogram with stress hormones andtiming of intervention at delivery and neonatal prognosis

Acronym

Interpretation of cardiotocogram with stress hormones andtiming of intervention at delivery and neonatal prognosis

Scientific Title

Interpretation of cardiotocogram with stress hormones andtiming of intervention at delivery and neonatal prognosis

Scientific Title:Acronym

Interpretation of cardiotocogram with stress hormones andtiming of intervention at delivery and neonatal prognosis

Region

Japan


Condition

Condition

pregnancy

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To minimize the deviation between fetal heart rate tracing and umbilical artery blood gas analysis, to avoid unnecessary cesarean section, and to improve the prognosis of the newborn.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation of cardiotocogram with stress hormones and umbilical artery blood gas

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

16 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

Pregnant women who deliver at our hospital

Key exclusion criteria

nothing

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mika
Middle name
Last name Sugihara

Organization

Kawasaki Medical School

Division name

department of obstetrics and gynecology

Zip code

701-0192

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

TEL

0864621111

Email

mika.m616@gmail.com


Public contact

Name of contact person

1st name Mika
Middle name
Last name Sugihara

Organization

Kawasaki Medical School

Division name

department of obstetrics and gynecology

Zip code

7010192

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

TEL

0864621111

Homepage URL


Email

mika.m616@gmail.com


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

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

Kawasaki Medical School

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

Tel

0864621111

Email

mika.m616@gmail.com


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

2021 Year 08 Month 22 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

2021 Year 08 Month 22 Day

Date of IRB


Anticipated trial start date

2021 Year 08 Month 22 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study


Management information

Registered date

2021 Year 08 Month 09 Day

Last modified on

2021 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name