Comparison of outcomes and complications of vaginal misoprostol Preoperative administration of oxytousin infusion during surgery to reduce bleeding during abdominal myomectomy
The aim of the study was to reduce bleeding during myomectomy via laparotomy in patients with uterine myoma is due to include women with uterine myoma laparotomy candidates and Interested to participate in the study and no Allergies for misoprostol or oxytocin and No consumption hormonal therapy Before surgery, no active liver or heart or renal or Pulmonary disorders or hypertention and
Coagulopathy.
105 female candidates for abdominal myomectomy referred to Zahra Hospital Medical Center are selected . infusion oxytocin 30 unit into 1000 ml normal saline speed of 120 ml/hour before starting anesthesia to Removing the compelete uterine from pelvic ( 35 patients) and misoprostol single dose of 400 mcg vaginally one hour before surgery during the operation the size of the oxytocin group received normal saline, recommends that ( 35 cases ) treated by routine non adminestration drug before and during surgery during the same volume of saline recommends that oxytocin group ( 35 cases ) on bleeding during myomectomy patients will be compared . For each of the study groups during the monitoring routine hemodynamic variables , primary outcome of reducing bleeding as bleeding ( the blood in suction and blood is absorbed in sponges to long Gas 50 cc and gas 5 ml )
It is estimated and Subsequent outcome hemoglobin before and after the surgery and the need for blood transfusion and durtion of hospitalization and durtion of surgery as measured by the three groups will be compared .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050210901N6
Registration date:2014-05-09, 1393/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-09, 1393/02/19
Registrant information
Name
Parvin Mostafa Gharebaghi
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
gharabagh.p@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-11-29, 1392/09/08
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes and complications of vaginal misoprostol Preoperative administration of oxytousin infusion during surgery to reduce bleeding during abdominal myomectomy
Public title
The effect of misoprostol on myomectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the desire to participate in the study
Exclusion Criteria: allergy to misoprostol or oxytocin; hormone therapy before surgery or gonadotropin releasing drugs such as oral contraceptive pills; active liver disorders - kidney disease - heart - lung ; candidates hysteroscopic myomectomy; hypertension ;coagulopathy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Street address
Army Street, Baghshomal Circle,Alzahra Hospital
City
tabriz
Postal code
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
5/4/11808
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
Bleeding
Timepoint
Day intervention
Method of measurement
The blood volume (amount of suction blood and blood absorbed in sponges to longGas 50cc and gas 5cc )
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
Since the intervention to patient discharge from the hospital
Method of measurement
documentation in the file
2
Description
Duration of surgery
Timepoint
Begin operation until the completion of surgery
Method of measurement
documentation in the file
3
Description
hemoglubin 6 hours after Surgery
Timepoint
6 hours after intervention
Method of measurement
Testing the file
4
Description
hemoglubin 24 hour after surgery
Timepoint
24 hours after intervention
Method of measurement
Testing the file
5
Description
blood transfusion
Timepoint
Since the intervention to patient discharge from the hospital
Method of measurement
documentation in the file
Intervention groups
1
Description
infusion oxytocin 30 unit into 1000 ml normal saline speed of 120 ml/hour before starting anesthesia to Removing the compelete uterine from pelvic
Category
Prevention
2
Description
A single dose of 400 mcg of misoprostol vaginally one hour before surgery
Category
Prevention
3
Description
non adminestration drug before and during surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahra hospital
Full name of responsible person
sakineh alizadeh
Street address
Army Street, Baghshomal Circle,Alzahra Hospital
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Female Reproductive Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Ms. Oshaghi
Street address
Al Zahra Hospital - Women's Reproductive Research Center, Tabriz University of Medical Sciences
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Female Reproductive Research Center, Tabriz 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
Resident Obstetric
Full name of responsible person
Sakineh Alizadeh doctor
Position
Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Al Zahra Hospital
City
tabriz
Postal code
Phone
+98 41 1553 9163
Fax
Email
s.alizadeh80@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Doctor Parvin Mostafaa Gharabaghi
Position
Oncology fellowship of women
Other areas of specialty/work
Street address
Hospital Alzahra
City
tabriz
Postal code
Phone
+98 41 1553 9163
Fax
Email
Pm_gharabaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Alizadeh
Position
Resident Obstetric
Other areas of specialty/work
Street address
Al Zahra Hospital
City
tabriz
Postal code
Phone
+98 41 1553 9163
Fax
Email
s.alizadeh80@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)