UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007577 |
|---|---|
| Receipt number | 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 13:20:19 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008709
