UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016538 |
|---|---|
| Receipt number | R000019168 |
| Scientific Title | Study of the improvement of anesthetic method for cervical cerclage |
| Date of disclosure of the study information | 2015/02/15 |
| Last modified on | 2018/07/23 16:37:00 |
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Basic information
Public title
Study of the improvement of anesthetic method for cervical cerclage
Acronym
Study of the improvement of anesthetic method for cervical carclage
Scientific Title
Study of the improvement of anesthetic method for cervical cerclage
Scientific Title:Acronym
Study of the improvement of anesthetic method for cervical carclage
Region
| Japan |
Condition
Condition
Cervical Insufficiency
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of adding morphine and fentanyl to local anesthetic in spinal anesthesia for cervical cerclage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The analgesic effect of intraoperative and postoperative period
Need for additional analgesic
Key secondary outcomes
The side effects for the patient and fetus
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patient undergoing cervical cerclage
Key exclusion criteria
Contraindications to spinal anesthesia
Contraindications to morphine or fentanyl
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Dept.Anesthesiology
Zip code
Address
4-23-15,Kotobashi,Sumida-ku,Tokyo,Japan
TEL
03-3633-6151
hirano.k.a.1980@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Dept.Anesthesiology
Zip code
Address
4-23-15,Kotobashi,Sumida-ku,Tokyo,Japan
TEL
03-3633-6151
Homepage URL
hirano.k.a.1980@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 02 | 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
Compared to the same number of consecutive cases before the study, administration of morphine and fentanyl to the spinal subarachnoid space significantly increased the analgesic effect during and after the operation. Although there was no serious side effect, the incidence of itching sensation was higher in the opioid administration group.
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 10 | Day |
Other
Other related information
Evaluate the improvement of intraoperative and postoperative analgesia and the side effects to the mother and fetus of adding morphine and fentanyl to local anesthetic during spinal anesthesia for cervical cerclage.
Management information
Registered date
| 2015 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019168
