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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Mother and her baby born under labor analgesia | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Key exclusion criteria | Patients with multiple pregnancies.
Patients with intrauterine fetal growth restriction. Patients with pregnancy complication. Patients with congenital anomalies in the fetus. |
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Target sample size | 250 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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 |
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Last modified on |
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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 |