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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016545
Receipt No. R000019131
Scientific Title Improvement of anesthetic method for cervical cerclage: a prospective interventional study
Date of disclosure of the study information 2015/03/15
Last modified on 2018/08/03

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Basic information
Public title Improvement of anesthetic method for cervical cerclage: a prospective interventional study
Acronym Improvement of anesthetic method for cervical cerclage: a prospective interventional study
Scientific Title Improvement of anesthetic method for cervical cerclage: a prospective interventional study
Scientific Title:Acronym Improvement of anesthetic method for cervical cerclage: a prospective interventional study
Region
Japan

Condition
Condition Cervical Insufficiency
Classification by specialty
Obsterics 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 the fetus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group with administration of morphine and fentanyl with an addition of local anesthetic in spinal anesthesia for cervical cerclage.
Interventions/Control_2 Group with administration of only local anesthetic in spinal anesthesia for cervical cerclage.
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 Contraindication to spinal anesthesia
Contraindication to morphine or fentanyl
Target sample size 24

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
Email atsuko12_23@yahoo.co.jp

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
Email atsuko12_23@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Bokutoh Hospital
Institute
Department

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
Email

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 03 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 15 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019131

Research Plan
Registered date File name
2018/07/23 子宮頸管縫縮術 前向き研究 臨床計画計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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