Protocol summary

Summary
This is a Single-blind randomized controlled clinical trial will be done in Imam Reza hospital in Kermanshah Iran. Inclusion criteria: all women undergoing abdominal hysterectomy for benign gynecologic disease and Exclusion criteria include patients who have contraindications to misoprostol, including mitral stenosis, heart disease, glaucoma, sickle cell anemia, severe hypertension, diastolic blood pressure above 100 mm / hg, severe asthma, or known hypersensitivity to prostaglandins, known endometriosis patients with a history of pelvic or active disease, diabetes, obesity (BMI> 30), a history of previous myomectomy and previous use of GnRH agonists before surgery, patients with invasive cancer endometrial, cervical and ovarian tumors. It is estimated sample size of 60 patients in the study group (1) 2 tablets of 200 mcg misoprostol an hour before practice and in the control group (placebo) pill vitamin B6 two an hour before the operation placed under the tongue. The primary outcome measure of intra operative blood lost include blood collection obtained by bottles suction and the weight difference between wet and dry gauze. Length of surgery from incision to skin closure, Hb level before and 24 hour after surgery, need to transfusion, length of hospital stay and fever ask secondary outcome measure will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610224025N8
Registration date: 2016-11-22, 1395/09/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-22, 1395/09/02
Registrant information
Name
Anisodowleh Nankali
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
anankali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sublingual misoprostol on intraoperative blood loss prior to abdominal hysterectomy.
Public title
sublingual misoprostol on intraoperative blood loss prior to abdominal hysterectomy.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: all women undergoing abdominal hysterectomy for benign gynecologic disease and Exclusion criteria include patients who have contraindications to misoprostol, including mitral stenosis, heart disease, glaucoma, sickle cell anemia, severe hypertension, diastolic blood pressure above 100 mm /Hg, severe asthma, or known hypersensitivity to prostaglandins, known endometriosis patients with a history of pelvic or active disease, diabetes, obesity (BMI> 30), a history of previous myomectomy and previous use of GnRH agonists before surgery, patients with invasive cancer endometrial, cervical and ovarian tumors.
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah -Sorkhe Lyzheh-medical School
City
Kermanshah
Postal code
6714869914
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
kums.rec.1394.133

Health conditions studied

1

Description of health condition studied
Hysterectomy
ICD-10 code
XIV Diseas
ICD-10 code description
N99-N99 Other disorders of the genitourinary system

Primary outcomes

1

Description
blood loss
Timepoint
intra operative
Method of measurement
Total blood volume in the suction bottle + weight difference between dry and wet gauze

Secondary outcomes

1

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

2

Description
Degree of fever after surgery
Timepoint
24 hours after surgery
Method of measurement
Thermometer

3

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

4

Description
The need for blood transfusions
Timepoint
Intraoperative and postoperative
Method of measurement
On hemoglobin level and Severity of bleeding

Intervention groups

1

Description
Population study Will be divided into two groups. study group(Group 1) and control group (Group 2).In study group 2 pills equal to 400 mcg misoprostol and in control Group 2 pills vitamin B6 will be placed under the tongue one hour before the surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza teaching hospital
Full name of responsible person
Dr. Tayebe Noori
Street address
Kermanshah, Sorkhalyzhe, Imam Reza teaching hospital
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research   Kermanshah University of Medical Sciences
Full name of responsible person
Dr . Behrooz Hamzeh
Street address
Kermanshah, shahid Beheshti Blvd., Building No. 2,Vice Chancellor for Research and Technology
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research   Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Tayebe Noori
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences Sorkhe Lyzheh- Imam Reza teaching hospital-Office of Women's Education
City
Kermanshah
Postal code
67144-15333
Phone
+98 918 387 0264
Fax
+98 34276477
Email
dr.tayebe_noori@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Anisodowleh Nankali
Position
Associate Professor   Kermanshah University of Medical Sciences,
Other areas of specialty/work
Street address
Kermanshah University of Medical Science Sorkhe Lyzheh- Imam Reza teaching hospital-Office of Women's Education
City
Kermanshah
Postal code
67144-15333
Phone
+98 83342763018
Fax
Email
anis_nankali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tayebe Noori
Position
resident of obstetrices and gynecology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences - Sorkhe Lyzheh- medical School
City
Kermanshah
Postal code
6714869914
Phone
+98 833427461821
Fax
Email
dr.tayebe_noori@yahoo.commaryam_hematti@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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