UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029747 |
|---|---|
| Receipt number | R000033985 |
| Scientific Title | Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomectomy |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2019/05/01 16:02:00 |
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Basic information
Public title
Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomectomy
Acronym
Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomecttomy
Scientific Title
Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomectomy
Scientific Title:Acronym
Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomecttomy
Region
| Africa |
Condition
Condition
recruiting
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to determine which is superior in reducing blood loss during myomectomy the intramyometrial carbetocin or rectal misoprostol
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative Blood loss during myomectomy
Operative time
Key secondary outcomes
operative complications
Hematocrit after 24 hours of operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intramyometrial injection of carbetocin during operation of myomectomy
Interventions/Control_2
rectal misoprostol preoperative
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Intramural myoma >= 4cm
single myoma
symptomatic myoma
Key exclusion criteria
Previous operation either myomectomy or cesarean section
Any bleeding disorders
Any medical disease eg: hypertension, renal, liver or heart diesase
Any myoma rather than intramural
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Ayman shehata dawood
Zip code
31111
Address
Tanta, gharbia, Egypt
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Obstetrics and gynecology
Zip code
31111
Address
Tanta, gharbia, Egypt
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
No sponsor
Institute
Department
Personal name
Funding Source
Organization
Tanta university
Obstetrics and gynecology department
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
Tanta university
Address
Tanta, gharbia, Egypt
Tel
00201020972067
ayman.dawood@med.tanta.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Marwa saad
Org. issuing International ID_1
Tanta University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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
60
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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033985
