This study aimed to compare the effect of 200 micrograms sublingual misoprostol , 400 micrograms sublingual misoprostol and 20 IU Oxytocin in reduction of bleeding during cesarean section. One hundred eighty candidate for Cesarean section with Incision in Lower Segment of uterus, in Imam Reza Hospital during 2011-2012 were included in this randomized, prospective, double-blind and placebo-controlled study. Patients were divided into three equal groups randomly. Group I received 200 micrograms sublingual misoprostol plus 200 micrograms sublingual placebo , Group II received 400 micrograms sublingual misoprostol ,Group III received 400 micrograms placebo sublingually and infusion of 20 IU oxytocin in 1 mL normal saline (300 mL/h), just after fetal expulsion. the calculated blood loss was based on gathered blood in suction dish and the number of bloody gases. this calculation was performed by an educated but unaware nurse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109104025N4
Registration date:2011-12-12, 1390/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-12, 1390/09/21
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
Vice chancellor for research Kermanshah University of Medical Sciences.
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Public title
Comparison of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Elective or Emergency Cesarean Deliveries with Incision in Lower Segment of uterus, Gestational Age more than 37 Weeks
Exclusion criteria:Anemia;Multiple pregnancy;Polyhydraminus;Prolonged labor;Premature rupture of membrane, History of diabetes mellitus,Hypertension,Cardiovascular disease,coagulopathy disorders, Placenta Previa & Placenta Abruption, Vaginal Bleeding.
Age
From 15 years old to 44 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical sciences.
Street address
Building number2,Shahid Beheshti blvd.
City
Kermanshah
Postal code
Approval date
2011-06-14, 1390/03/24
Ethics committee reference number
73521/024/7/پ
Health conditions studied
1
Description of health condition studied
Child birth and priperium
ICD-10 code
O00-O99
ICD-10 code description
O60-O75
Primary outcomes
1
Description
Intraoperative bleeding
Timepoint
At the time of surgery
Method of measurement
Measured with the blood suctioned in cc by the graded container
Secondary outcomes
1
Description
Fever
Timepoint
During 48 hrs after surgery, measured every 3 hours
Method of measurement
Persist fever more than 38 ° c, with thermometer
2
Description
Change in basal pulse rate
Timepoint
Before surgery & intraoperative & 6 hrs after surgery
Method of measurement
Pulse rate in one minute
3
Description
Changing of blood pressure
Timepoint
Before surgery & intraoperative & 6 hrs after surgery
Method of measurement
Measuring with Sphygmomanometer
4
Description
Diarrhea
Timepoint
Before & 6 hrs after surgery
Method of measurement
question about change in frequency of defecation or its consistency (watery stool)
5
Description
Vomiting
Timepoint
Before & 6 hrs after surgery
Method of measurement
Question about forceful expulsion of stomach contents
Intervention groups
1
Description
Intervention group:sublingual misoprostol 200micrograms
Control groups:Infusion20 unit oxytocin,misoprostol 400 micrograms