The purpose of this study was to compare the effect of general anesthesia and spinal anesthesia on hemoglobin concentration after cesarean section. The study randomized, double-blind, placebo be conduct without control. 220 pregnant women reffered to Khatamol anbia Hospital with gestational age 38 to 40 weeks of pregnancy with less than or equal to 5 that the operation time is less than 90 minute that have not medical and obstetric problems which may increase the risk of bleeding during labor were divided in two groups general anesthesia and spinal anesthesia.Hemoglobin and hematocrit 6 and 24 hours after cesarean section were measured in both groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110612642N21
Registration date:2015-11-17, 1394/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-17, 1394/08/26
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Zahedan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of general anesthesia and spinal anesthesia on hemoglobin concentration after cesarean section
Public title
The effect of anesthesia on changes in hemoglobin after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Gestasional age between 38-40weeks; Single; gravidity less than or equal to 5; parity less than or equal to 4. exclusion criteria: Atonic uterus; preeclampsia; coagulation disorders; placental abruption; emergent caesarean; Birth weight over 4 kg; operation time over 90 minutes; heart problems; preterm labor; uterine myoma; Medical and obstetric problems which may increase the risk of bleeding during labor.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
220
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi.Squ
City
Zahedan
Postal code
Approval date
2013-09-29, 1392/07/07
Ethics committee reference number
6004
Health conditions studied
1
Description of health condition studied
The effect of anesthesia on bleeding
ICD-10 code
O29.8
ICD-10 code description
Other complications of anaesthesia during pregnancy
Primary outcomes
1
Description
Hemoglobin
Timepoint
The day before and 6 hours and 24 hours after surgery
Method of measurement
According to the lab and on the basis grams per deciliter
2
Description
Hematocrit
Timepoint
The day before and 6 hours and 24 hours after surgery
Method of measurement
According to the lab and on the basis percent
3
Description
duration time of surgery
Timepoint
Intraoperative
Method of measurement
The time between cutting the skin with its restoration in minutes
Secondary outcomes
1
Description
patient's age
Timepoint
Before entering the scheme
Method of measurement
Basis on age
2
Description
Gestational age
Timepoint
Before entering the scheme
Method of measurement
According to the first ultrasonic by week
Intervention groups
1
Description
In the first group (general anesthesia) induction of anesthesia with 5 mg per killogeram body weight sodium thiopental to perform endotracheal intubation direction of one and a half milligrams per kilogram of body weight is used succinylcholine
Category
Prevention
2
Description
In the second group (spinal anesthesia) ziro point five percentage bupivacaine in the sitting position by spinal needle is injected into the subarachnoid space.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Ali ebne abitaleb Hospital
Full name of responsible person
Alireza Jahangirifard
Street address
Darabad Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Mahmoodzadeh Sagheb
Street address
Dr Hesabi.Squ
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zahedan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Departman of Anesthesiology of Shahid Beheshti University Of Medical Science
Full name of responsible person
Alireza Jahangirifard
Position
Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Departman of Anesthesiology of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)