Determination and comparison of bleeding after myomectomy in patients receiving misoprostol and placebo control group
Design
The samples are randomly assigned to one of the two intervention and control groups using the software. In this way, all possible four blocks that include two groups are written and each number is assigned to one of the blocks in the table. Based on the table of random numbers obtained by a computer program, a block is selected and based on that, the samples entered into the study will be entered into different groups.
A total of 34 samples were determined in each group (a total of 68 samples).
Settings and conduct
Individuals will be randomly assigned to computer groups one and two. People in group one will receive a dose of 200 micrograms of vaginal misoprostol (before surgery in the operating room before the patient's forehead) and the control group will receive B6 tablets vaginally.
The surgical procedure for all patients includes the standard standard open myomectomy surgery performed by a physician at Sayad Shirazi Hospital. And the amount of bleeding during the operation is measured based on accurate suction, gas and lameness.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years
Myoma less than 8 cm in size on ultrasound
Married
Exclusion criteria:
Contraindications to misoprostol
Hemorrhagic disease
Active asthma
High diastolic blood pressure
Recent use of nonsteroidal anti-inflammatory drugs
History of severe anemia; Allergies and recent blood transfusions
Intervention groups
The intervention group, who will receive a dose of 200 micrograms of vaginal misoprostol (before surgery in the operating room)
Control group: The control group will receive B6 pills vaginally.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220101053581N1
Registration date:2022-05-21, 1401/02/31
Registration timing:registered_while_recruiting
Last update:2022-05-21, 1401/02/31
Update count:0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
maryam mazji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3523 2001
Email address
m_mazji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of vaginal misoprostol on post myomectomy bleeding: A double-blind randomized clinical trial
Public title
Survey of the effect of vaginal misoprostol on post myomectomy bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Myoma less than 8 cm in size on ultrasound
married
Exclusion criteria:
Contraindications to misoprostol
Hemorrhagic disease
Active asthma
High diastolic blood pressure
Recent use of nonsteroidal anti-inflammatory drugs
History of severe anemia; Allergies and recent blood transfusions
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were divided into control and intervention groups based on random allocation of quadruple blockade. For this purpose, the four blocks were selected so that the intervention group had the letter A and the control group the letter B. 6 possible modes were written on separate cards and each card was assigned a number from one to six. The numbers were then written on paper and removed randomly. Until the expected number of samples was completed. In this study, the online randomization service (http // www.sealedenvelope.com / simple-randomiser / v1 / lists) was used to block block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sequence concealment was performed using packets in packages. In this way, one of the letters was placed inside each envelope in the specified order and then the lid of the envelope was closed and given to the researcher. The use of random allocation largely controlled the confounding variables, but the research team also included potential confounding variables in the designed questionnaire and analyzed their effect. The researcher will also be unaware of the assignment of individuals in groups due to hiding the sequence of individuals in groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Sayad Shirazi Street, Sayad Shirazi Hospital
City
GORGAN
Province
Golestan
Postal code
74394917867
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.GOUMS.REC.1400.322
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, unspecified
Primary outcomes
1
Description
Reduce vaginal bleeding
Timepoint
During surgery and 6 hours after surgery
Method of measurement
Based on suction and gas and long gas
Secondary outcomes
1
Description
Decreased transfusion of blood products
Timepoint
6 hours after surgery
Method of measurement
Measurement of hemoglobin
Intervention groups
1
Description
After obtaining permission from the authorities and explanations about the method of intervention to patients and completing the form of demographic questionnaire, patients will be randomly divided into two groups of control and intervention. On the day of surgery before the start of the patient's surgery (in the patient preparation phase), patients with the intervention group will be administered 200 micrograms of misoprostol vaginally. Bleeding during the operation will then be estimated by the amount of gas and blood clot and suction.
Category
Treatment - Surgery
2
Description
patients in the control group, placebo (tablet B6) will be used vaginally before surgery and the amount of bleeding during the operation will be measured by measuring gas and blood clots and suction.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayad Shirazi Hospital, Gorgan
Full name of responsible person
Maryam Mazji
Street address
Sayad Shirazi Hospital, Gorgan
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2173
Fax
+98 17 3220 4175
Email
m_mazji@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Gorgan Kordkoy Road, Philosophy Educational Complex, Vice Chancellor for Research and Technology
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ - ۴۹۳۴۱
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
Sayyadlib@goums.ac.ir
Web page address
https://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Maryam Mazji
Position
The Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sayad Shirazi Hospital, Gorgan
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2173
Email
m_mazji@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marzieh Zanganeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sayad Shirazi Hospital, Gorgan
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2173
Email
marzieh.zanganeh90@gmail.com
Web page address
https://isid.research.ac.ir/Marzieh_Zanganeh
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Maryam Mazji
Position
REZIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sayad Shirazi Hospital, Gorgan
City
Gorgan
Province
Golestan
Postal code
:۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2173
Email
m_mazji@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the main outcome data includes personal information and the main outcome results
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
Only researchers to conduct similar studies
From where data/document is obtainable
Dr. Maryam Mazji
Email: m_mazji@yahoo.com
What processes are involved for a request to access data/document