Protocol summary

Summary
(1) Objectives, The aim of this study is comparison effect of general and spinal anesthesia on hemoglobin and hematocrit value after cesarean section. (2) Design, This study was performed in a clinical trial on two groups of general anesthesia and spinal anesthesia. (3) Setting and conduct, after talking written consent about type of anesthesia, all patients received 10 mg intravenous metoclopramide and 500 milliliters of Ringer lactate. In control group, 42 patients received spinal anesthesia with 12 mg of bupivacacaine on lumbar 2 &3 spaces. In intervention group forty six patients received general anesthesia with sodium thiopental 5 mg/kg, succinyl choline 1.5 mg/kg, Isoflorane 0.75, N2O 50%and O2. (4) Participants including major eligibility criteria, Inclusion criteria is American Society Anestesiology class1 pregnant women who were candidate for elective cesarean. Exclusion criteria were systemic disease, fetal distress, preterm pregnancy, multiparous pregnancy,decolman, atony . (5) Intervention, administration of sodium thiopental 5 mg/kg, succinyl choline 1.5 mg/kg, Isoflorane 0.75, N2O 50%and O2. (6) Main outcome measures (variables), 24 h Preoperative and 24 h postoperative hemoglobin and hematocrit values and Apgar score were recorded in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201510087752N7
Registration date: 2015-12-19, 1394/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-19, 1394/09/28
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research,Babol University of Medical Sciences
Expected recruitment start date
2009-11-10, 1388/08/19
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of General and Spinal Anesthesia on Hemoglobin and Hematocrit Value in Women after Cesarean Section
Public title
Comparison Effect of General and Spinal Anesthesia on Hemoglobin and Hematocrit after Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Pregnant woman; elective cesarean ; ASA class =1 Exclusion criteria: Systemic disease ;Emergency cesarean; fetal distress;Preterm pregnancy;Multiparous pregnancy; Decolman; Atony;Surgical time greater than 1 hour .
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Babol University of Medical Siences
Street address
Babol University of Medical Sciences,Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Postal code
471764136
Approval date
2009-11-10, 1388/08/19
Ethics committee reference number
83/90/325

Health conditions studied

1

Description of health condition studied
cesarean Section
ICD-10 code
089.2
ICD-10 code description
Delivery by caesarean section, unspecified

Primary outcomes

1

Description
Hemoglobin
Timepoint
Preoperation,24 hours after surgury
Method of measurement
Miligram per desilitr

2

Description
Hematocrit
Timepoint
Preoperation,24 hours after surgury
Method of measurement
Percent

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Basic,After incision,After skeen closure
Method of measurement
Millimeter per silver

2

Description
APEGARE Score
Timepoint
1,5 minutes afer birth
Method of measurement
Number

Intervention groups

1

Description
The intervention group received general anesthesia with Isoflorane 0. 75, N2O 50%and O2 .
Category
Treatment - Drugs

2

Description
The control group received spinal anesthesia with 12 mg of bupivacacaine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rohani Teaching Hospital
Full name of responsible person
Amri Maleh Parviz
Street address
Rohany teaching Hospital, Ganjafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Moghaddamnia Ali
Street address
Babol University of Medical Sciences, Gangafrooz St, Daneshgah Square, Babol, Iran
City
Babol
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, Babol 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
Vice-chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Amri Maleh Parviz
Position
Associated professor/Anestesiologist
Other areas of specialty/work
Street address
Rohany Hospital, Gangafrooz Street, Daneshgah Spuare, Babol, Mazandaran, Iran
City
Babol
Postal code
4717641376
Phone
+98 11 4207 4589
Fax
+98 11 3223 8284
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice-chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Amri Maleh Parviz
Position
Associated professor/Anesthesiologist
Other areas of specialty/work
Street address
Rohany Hospital, Gangafrooz Street,Daneshgah Square, Babol, Mazandaran, Iran Babol
City
Babol
Postal code
4717641376
Phone
+98 11 4207 4589
Fax
+98 11 3223 8284
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vice-chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Amri Maleh Parviz
Position
Associated professor/Anestesiologist
Other areas of specialty/work
Street address
Rohny Hospital, Ganjafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Postal code
4717641376
Phone
+98 11 4207 4589
Fax
+98 11 3223 8284
Email
pamrimaleh@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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