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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048033
Receipt No. R000054584
Scientific Title A prospective observational study of anesthetic concentration in umbilical cord blood and neonatal health status under epidural analgesia for labor.
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/11

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Basic information
Public title A prospective observational study of anesthetic concentration in umbilical cord blood and neonatal health status under epidural analgesia for labor.
Acronym A prospective observational study of anesthetic concentration in umbilical cord blood and neonatal health status under epidural analgesia for labor.
Scientific Title A prospective observational study of anesthetic concentration in umbilical cord blood and neonatal health status under epidural analgesia for labor.
Scientific Title:Acronym A prospective observational study of anesthetic concentration in umbilical cord blood and neonatal health status under epidural analgesia for labor.
Region
Japan

Condition
Condition Mother and her baby born under labor analgesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure umbilical cord blood anesthetic concentration under labor analgesia with ropivacaine and fentanyl. We study the relationship between umbilical cord blood anesthetic concentration and neonatal health status.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between umbilical cord blood anesthetic concentration and neonatal health status.
Key secondary outcomes The relationship between umbilical cord blood anesthetic concentration and drug administration during labor analgesia.

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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Pregnant women planning to undergo labor analgesia.
Patients with singleton pregnancy.
Patients whose delivery is between 37 and 42 weeks gestation.
Patients who can communicate in Japanese.
Key exclusion criteria Patients with multiple pregnancies.
Patients with intrauterine fetal growth restriction.
Patients with pregnancy complication.
Patients with congenital anomalies in the fetus.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Arisa
Middle name
Last name Ijuin
Organization National center for child health and development
Division name Department of clitical care and anesthesia
Zip code 157-8535
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416--0181
Email ijyuin-a@ncchd.go.jp

Public contact
Name of contact person
1st name Arisa
Middle name
Last name Ijuin
Organization National center for child health and development
Division name Department of clitical care and anesthesia
Zip code 157-8535
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Homepage URL
Email ijyuin-a@ncchd.go.jp

Sponsor
Institute National center for child health and development
Institute
Department

Funding Source
Organization National center for child health and development
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National center for child health and development
Address 2-10-1 Okura, Setagaya-ku, Tokyo
Tel 03-3416-0181
Email rinri@ncchd.go.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
2022 Year 06 Month 15 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
2022 Year 06 Month 10 Day
Date of IRB
2022 Year 06 Month 03 Day
Anticipated trial start date
2022 Year 07 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We measure umbilical cord blood anesthetic concentration under epidural labor analgesia.
We investigate the relationship between umbilical cord blood anesthetic concentration and neonatal health status.
We examine the relationship between drug adminstration and umbilical cord blood anesthetic concentration.

Management information
Registered date
2022 Year 06 Month 11 Day
Last modified on
2022 Year 06 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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