UMIN-CTR Clinical Trial

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	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
Last 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
Email	ayman.dawood@med.tanta.edu.eg

Public contact
1st 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
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	No sponsor
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)

IRB Contact (For public release)
Organization	Tanta university
Address	Tanta, gharbia, Egypt
Tel	00201020972067
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033985