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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name