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Effect of rectal Misoprostol in reducing blood loss before hysterectomy and myomectomy

Protocol summary

Study aim
Determining the effect of rectal misoprostol on reducing blood loss before hysterectomy and myomectomy
Design
Clinical trial with community-based and pragmatic control group, with parallel groups, double-blind, randomized
Settings and conduct
This double-blind clinical trial is performed on candidates for total hysterectomy with and without bilateral salpingo-ovariectomy and myomectomy due to symptomatic uterine fibromas that are admitted to the surgical ward of the Ayatullah Rohani hospital in Babol in 2017.
Participants/Inclusion and exclusion criteria
Age between 35 and 50 years, The number of uterine fibroids is 5 or less, The maximum size of the largest fiber is 3 cm, all fibroids are subserosa or intramural in ultrasound, Uterus size in two-handed examination is less than 24 weeks pregnancy if need for myomectomy, Exclusion criteria: Any contraindication for using Misoprostol, The presence of malignancy, History of previous laparotomy except cesarean section, History of endometriosis, Cardiovascular and pulmonary diseases, Bleeding disorders, Hemoglobin below 10 g / dl, Body mass index greater than 30 kg / m², Previous Myomectomy history, History of using misoprostol with GnRH immediately before surgery, Unwillingness to enter the study.
Intervention groups
The first group will receive 400 micrograms misoprostol (200 μg P.I.C High Wycombe, England) and the second group will receive placebo, rectally 30 minutes before surgery.
Main outcome variables
bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181020041394N1
Registration date: 2018-11-30, 1397/09/09
Registration timing: registered_while_recruiting

Last update: 2018-11-30, 1397/09/09
Update count: 0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Azita Ghanbarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
a.ghanbarpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-13, 1397/03/23
Expected recruitment end date
2019-06-13, 1398/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of rectal Misoprostol in reducing blood loss before hysterectomy and myomectomy
Public title
Effect of rectal Misoprostol in reducing blood loss before hysterectomy and myomectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35 and 50 years The number of uterine fibroids is 5 or less The maximum size of the largest fiber is 3 cm All fibromas are subserosal or intramural in ultrasound Uterus size less than 24 weeks pregnant with two-handed examination if need for myomectomy
Exclusion criteria:
Any contraindication for using Misoprostol The presence of malignancy History of previous laparotomy except cesarean section History of endometriosis Cardiovascular and pulmonary diseases Bleeding disorders Hemoglobin below 10 g / dl Body mass index greater than 30 kg / m² Previous Myomectomy History History of using misoprostol with GnRH immediately before surgery Unwillingness to enter the study
Age
From 35 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups by a simple random method. In this research, the coin toss will be used to create a random sequence in a two-group trial. So that one of the study groups is tail and the other group is considered as a head, and according to the sample size, the same amount of coin is tossed and the subjects are divided into two groups of random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, nurses and researcher are blind in this study, and drug therapy is based on codes only by the head nurse of the gynecology department.
Placebo
Used
Assignment
Parallel
Other design features
.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
478956-1
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.114

Health conditions studied

1

Description of health condition studied
Uterine lymphoma
ICD-10 code
D25
ICD-10 code description
benign neoplasms of uterus with morphology code M889 and behaviour code /0 fibromyoma of uterus

Primary outcomes

1

Description
Amount of bleeding during surgery
Timepoint
After the end of the surgery
Method of measurement
Volume of available hemorrhage in the suction device and the counting and calculation of blood gases

2

Description
Postoperative hemoglobin loss
Timepoint
Before surgery and 6 hours after surgery
Method of measurement
In grams per dL of the blood sample before surgery and 6 hours after surgery

Secondary outcomes

1

Description
Complications after surgery
Timepoint
From the time of transfer to the department up to two weeks after the operation
Method of measurement
The incidence of complications is noted

2

Description
The incidence of complications during surgery
Timepoint
During surgery
Method of measurement
The incidence of complications is noted

3

Description
Length of the surgery
Timepoint
During surgery
Method of measurement
From the time of the initial entry of the laparoscopic tooth skinning to the skin in minutes

4

Description
Hemodynamic changes during surgery
Timepoint
During surgery
Method of measurement
The mean of vital signs registered during anesthesia by anesthesiologist is in mm of mercury (blood pressure), beats per minute (heart rate), centimeters (body temperature)

Intervention groups

1

Description
Intervention group: The first group received 400 micrograms of rectal misoprostol (200 micrograms, P.I.C., High Wycombe, England) 30 minutes before surgery.
Category
Treatment - Drugs

2

Description
Control group: The second group received rectal placebo 30 minutes before surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Ayatullah Rouhani Babol
Full name of responsible person
Dr. Azita Ghanbarpour
Street address
Ayatullah Rouhani Hospital in Babol, Ganj Afrooz Avenue
City
Babol
Province
Mazandaran
Postal code
147896-1
Phone
+98 11 3225 6285
Email
a.ghanbarpour@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
147896-1
Phone
+98 11 3225 6285
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Azita Ghanbarpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
147896-1
Phone
+98 11 3225 6285
Email
a.ghanbarpour@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Maedeh Molla Alipour
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
147896-1
Phone
+98 11 3222 7667
Email
neda_amani69@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Azita ghanbarpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
147896-1
Phone
+98 11 3225 6285
Email
a.ghanbarpour@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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