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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029747
Receipt No. R000033985
Official scientific title of the study 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 2017/10/29

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Basic information
Official scientific title of the study Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomectomy
Title of the study (Brief title) Effect of intramyometrial injection of carbetocin versus rectal misoprostol on blood loss during myomecttomy
Region
Africa

Condition
Condition recruiting
Classification by specialty
Obsterics 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 Ayman Shehata Dawood
Organization Tanta university
Division name Ayman shehata dawood
Address Tanta university
TEL +201020972067
Email ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person Ayman shehata dawood
Organization Tanta university
Division name Obstetrics and gynecology
Address Tanta university
TEL +201020972067
Homepage URL
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta university
department of obstetrics and gynecology
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 10 Month 29 Day
Last modified on
2017 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033985

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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