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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014141
Receipt No. 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

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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
Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email noriko198112162000@yahoo.co.jp

Sponsor
Institute tokyo metropolitan tama medical center department of anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016380


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