UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014141 |
|---|---|
| Receipt number | R000016380 |
| Scientific Title | comparison between methylergometrine and oxytocin for perioperative bleeding in elective cesarean section. |
| Date of disclosure of the study information | 2014/06/02 |
| Last modified on | 2015/02/12 18:29:53 |
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Basic information
Public title
comparison between methylergometrine and oxytocin for perioperative bleeding in elective cesarean section.
Acronym
comparison between methylergometrine and oxytocin for perioperative bleeding in elective cesarean section.
Scientific Title
comparison between methylergometrine and oxytocin for perioperative bleeding in elective cesarean section.
Scientific Title:Acronym
comparison between methylergometrine and oxytocin for perioperative bleeding in elective cesarean section.
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between the amount of bleeding with oxytocin and methylergometrine in elective caesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the amount of intraoperative bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved 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
Methylergometrine group
Interventions/Control_2
Oxycitocin group
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Full term delivery
not amniorrhexis
singleton
Key exclusion criteria
polycyesis
oligohydramnios,hydramnios
placenta previa,placent accreta
PIH or other complication
tocolysis just before operation
general anesthesia
urgent cesarean section
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujii Noriko |
Organization
tokyo metropolitan tama medical center
Division name
department of anesthesiology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-323-5111
noriko198112162000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Fujii |
Organization
tokyo metropolitan tama medical center
Division name
department of anesthesiology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-323-5111
Homepage URL
noriko198112162000@yahoo.co.jp
Sponsor or person
Institute
tokyo metropolitan tama medical center department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 06 | Month | 02 | 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
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | 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
| 2014 | Year | 06 | Month | 02 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016380
