UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051325 |
|---|---|
| Receipt number | R000058329 |
| Scientific Title | A prospectve observational study of maternal and umbilical blood anesthetic concentration and neonatal health status in the case of conversion from epidural labor analgesia to cesarean section. |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/07/04 13:37:47 |
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Basic information
Public title
A prospectve observational study of maternal and umbilical blood anesthetic concentration and neonatal health status in the case of conversion from epidural labor analgesia to cesarean section.
Acronym
A prospectve observational study of maternal and umbilical blood anesthetic concentration and neonatal health status in the case of conversion from epidural labor analgesia to cesarean section.
Scientific Title
A prospectve observational study of maternal and umbilical blood anesthetic concentration and neonatal health status in the case of conversion from epidural labor analgesia to cesarean section.
Scientific Title:Acronym
A prospectve observational study of maternal and umbilical blood anesthetic concentration and neonatal health status in the case of conversion from epidural labor analgesia to cesarean section.
Region
| Japan |
Condition
Condition
Mother and her baby who undergo cesarean secion using epidural catheter for labor analgesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure maternal and umbilical blood anesthetic concentration in the case of conversion from labor analgesia to cesarean section using ropivacain and fentanyl. We study the relationship between the anesthetic concentration and neontal health status.
Basic objectives2
Others
Basic objectives -Others
We study the relationship between the anesthetic concentration and maternal status.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We asses the neonatal health status immediately after birth. The neonatal health status includes Apgar score, umbilical cord artery blood pH, neonatal resuscitation, and admission to the NICU/GCU.
Key secondary outcomes
We evaluate the condition of the mother from the beginning of anesthetic administration for cesarean section to the end of cesarean section. We evaluate the presence of local anesthetic systemic toxicity and respiratory depression as a maternal condition.
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 plannning to undergo labor analgesia.
Pregnant women who can comunicate in Japanese.
Pregnant women with singlton pregnancy.
Pregnant women shose delivery in between 37 and 42 weeks gestation.
Key exclusion criteria
Pregnant women with congenital anomalies in the fetus.
Pregnant women with fetal growth restriction.
Target sample size
1000
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
Arisa Ijuin
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
| 2023 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 maternal venous anesthetic concentraion before drug administration and at delivery. We also measure umbilical venous anesthetic concentration at delivery.
We study the relationship between the anesthetic concentration and neonatal health status. The neonatal health status includes Apgar score, umbilical cord artery blood pH, neonatal resuscitation, and NICU/GCU admission.
We study the relationship between the anesthetic concentration and maternal health status.
Maternal status includes the presence or absence of local anesthetic systemic toxicity and respiratory depression.
Management information
Registered date
| 2023 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058329
| Research Plan | |
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| Registered date | File name |
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