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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007577
Receipt No. R000008709
Scientific Title The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section
Date of disclosure of the study information 2012/03/28
Last modified on 2013/01/04

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Basic information
Public title The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section
Acronym The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section
Scientific Title The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section
Scientific Title:Acronym The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section
Region
Japan

Condition
Condition Elective Cesarean section
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Oxytocin is routinely administered during Cesarean section to promote uterine contraction and reduce blood loss from the placental site. When administered as a rapid intravenous (i.v.) bolus, it causes abrupt hypotension, tachycardia and ECG changes and the i.v. administration of 10 units of oxytocin has been reported to cause cardiovascular collapse and death. Although there have been some studies to investigate the better methods of administration, there is only one report about the effects of intramyometrial oxytocin. Our clinical impression has been that the intramyometrial oxytocin, followed by a routine infusion, produces adequate uterine contraction with fewer adverse effects than the i.v. bolus injection. We have designed this randomized double-blind trial to compare the effects and adverse effects of intramyometrial oxytocin with intravenous oxytocin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The lowest systolic blood pressure and the highest heart rate within ten minute after the administration of oxytocin
Key secondary outcomes Uterine tone assessed by obstetricians
Blood loss during operation
The rate of patients administered additional uterotonics within 24hour after baby delivery
The adverse effects of oxytocin (nausea, vomiting, facial flushing)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Immediately after delivery of the baby and cord clamping, the obstetrician gives a 2mL intramyometrial test drug (0.07unit/kg oxytocin plus normal saline). At the same time, an anesthesiologist gives a 10mL test drug (normal saline) intravenously over 30seconds.
Interventions/Control_2 Immediately after delivery of the baby and cord clamping, the obstetrician gives a 2mL intramyometrial test drug (normal saline). At the same time, an anesthesiologist gives a 10mL test drug (0.07unit/kg oxytocin plus normal saline) intravenously over 30seconds.
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
45 years-old >
Gender Female
Key inclusion criteria ASA physical status 1 or 2, gestational age of over 36 weeks, elective Cesarean section
Key exclusion criteria More than two previous Cesarean sections, previous post-partum hemorrhage, known placenta previa, twin pregnancy, polyhydramnios, pregnancy induced hypertension
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigehito Sato
Organization Hamamatsu University School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 1-20-1 Handayama Higashi-ku Hamamatsu-shi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chieko Akinaga
Organization Hamamatsu University School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 1-20-1 Handayama Higashi-ku Hamamatsu-shi
TEL 053-435-2286
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology and Intensive Care
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 浜松医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 28 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 Completed
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 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
2012 Year 03 Month 27 Day
Last modified on
2013 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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