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Evaluating the effects of rectal misoprostol prior to myomectomy on the volume of hemorrhage in versus of placebo in al Zahra hospital patients with intramural myoma from 2017-2018

Protocol summary

Study aim
Evaluating the effect of preoperative rectal misoprostol administration on the volume of hemorrhage during and after myomectomy operation in patients with symptomatic interimural myoma admitted to Alzahra Dasal Hospital in 2017-2018
Design
A randomized, double blind clinical trial with parallel control and intervention groups was performed on 94 patients with myoma.
Settings and conduct
In this randomized clinical trial, patients referred to the Al-Zahra Educational Hospital during the years 2017-2018, which are referred to as symptomatic myomas, are evaluated. The operator fills in the encoded form (including demographic characteristics and delivery history according to medical records). The patient and the outcome evaluator of pain (second operator) do not know the nature of the codes (double blind study).
Participants/Inclusion and exclusion criteria
Inclusion criteria include:Women 18 to 50 years old,5 or less symptomatic myoma, intramoral myoma based on sonography, A minimum of 4 cm in size of myoma. Exclusion criteria:anemia (HB less than10),allergy to Misoprostol,Cardiopulmonary diseases ,Hemorrhage disorders,Body mass index more than 35,Uncontrolled blood pressure despite drug use,uterine size more than 24 weeks
Intervention groups
Before starting the operation, in the control group, placebo and in the intervention group, misoprostol 400 micrograms of rectal dosage was prescribed. Then its effect on bleeding during the operation and the level of hemoglobin 4 and 24 hours after surgery are compared.
Main outcome variables
the volume of hemorrhage during and after myomectomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080826001096N5
Registration date: 2018-04-26, 1397/02/06
Registration timing: registered_while_recruiting

Last update: 2018-04-26, 1397/02/06
Update count: 0
Registration date
2018-04-26, 1397/02/06
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of rectal misoprostol prior to myomectomy on the volume of hemorrhage in versus of placebo in al Zahra hospital patients with intramural myoma from 2017-2018
Public title
rectal misoprostol on intraoperative blood loss prior to abdominal myomectomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-50 years 5 or less symptomatic myoma intramoral myoma based on sonography A minimum of 4 cm in size of myoma (because no smaller than 4 cm can produce a lot of bleeding)
Exclusion criteria:
anemia (HB less than10) allergy to Misoprostol (By asking questions such as skin sign, hives, rash, shortness of breath, coughing, chest pain after the previous use of Miso Prostol) Cardiopulmonary diseases Hemorrhage disorders obese (Body Mass Index more than35) Uncontrolled blood pressure despite drug use uterine size more than 24 weeks
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized random blocking technique in one of the 4 blocks (aabb, abab, baba, bbaa) is divided into two groups receiving placebo, receiving misoprostol, by Skilled trained technician. The hemoglobin is measured and recorded before surgery in the laboratory. To be blinded, Misoprostol (Miso Glendine, Sami Mus) with a dose of 400 micrograms of rectal one hour before surgery by the head nurse of the electrocardiogram section, the midwife of the collaborator, who is not a research team, is placed in the patient. In the control group, a placebo tablet of the shape and size They are similar to misoprostol but contain inert material. All collected data is documented and recorded in hospital records. All surgical procedures are performed by the Fanstile cut.Numerical comparison and filling out all of the above information, separately and Double blind, are carried out by two gynecologic assistants.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in the study and the person who evaluated the outcome of the pain (second operator) do not know the nature of the codes (double blind study).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
• Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.GUMS.REC.1396.257

Health conditions studied

1

Description of health condition studied
myoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus

Primary outcomes

1

Description
Length of stay in hospital
Timepoint
From admission to exit
Method of measurement
day

Secondary outcomes

1

Description
Postoperative hemoglobin and hematocrit
Timepoint
4 and 24 hours after surgery
Method of measurement
blood test

2

Description
blood loss
Timepoint
Intraoperative and postoperative
Method of measurement
On hemoglobin level and Severity of bleeding Total blood volume in the suction bottle + wet gauze and long gauze

Intervention groups

1

Description
Intervention group: 2 pills equal to 400 mcg misoprostol will be placed rectal one hour before the surgery.
Category
Treatment - Drugs

2

Description
Control group: 2 pills vitamin B6 will be placed rectal one hour before the surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Dr.Seyedeh Hajar Sharami
Street address
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3336 9224
Email
sharami@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Research vice-chancellorship
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan university of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
Resident of Professor, Guilan university of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
f_hoseini@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Hajar Sharami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
sharami@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Attari
Position
MS of midwifery
Latest degree
Master
Other areas of specialty/work
Midvifery
Street address
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
maryam_atari4950@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
There is still planning to share and publish.
When the data will become available and for how long
The beginning of the access period is 6 months after the publication of the study results.
To whom data/document is available
All interested in study.
Under which criteria data/document could be used
En Not yet planned for it.
From where data/document is obtainable
sharami@gums.ac.ir
What processes are involved for a request to access data/document
Not yet planned for it.
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