UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048033 |
|---|---|
| Receipt number | 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 | 2025/07/27 16:15:02 |
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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
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
ijyuin-a@ncchd.go.jp
Sponsor or person
Institute
National center for child health and development
Institute
Department
Personal name
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
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
https://link.springer.com/article/10.1007/s12630-025-02975-7
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12630-025-02975-7
Number of participants that the trial has enrolled
50
Results
The ropivacaine and fentanyl concentrations were 77 [56-98] ng/mL and 0.125 [0.125-0.20] ng/mL at delivery, respectively. The umbilical analgesic concentrations were correlated with the labour duration and total dose.The umbilical arterial pH was over 7.2 and the Apgar score at 5 min was above 8 for all neonates. No neonates exhibited systemic local anesthetic toxicity. Respiratory support was required for 14 neonates.
Results date posted
| 2025 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 10 | Day |
Baseline Characteristics
A pregnant woman who gave birth with labor analgesia at the National Center for Child Health and Development, and her baby.
Participant flow
We consecutively recruited all pregnant people who requested labour analgesia at the National Center for Child Health and Development (Tokyo, Japan) between July and September 2022 for this prospective observational study. We obtained written informed consent from all participants.
Adverse events
None
Outcome measures
umbilical venous analgesic concentrations and neonatal characteristics.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054584
