UMIN-CTR Clinical Trial

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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