This study will be conducted as randomized clinical trial with control group to evaluate the effect of mother oxygen therapy on neonatal umbilical venous blood gas. Target population consists of one hundred healthy full term pregnant women that was candidate for cesarean section surgery. The inclusion criteria are: Single pregnancy, Body mass index less than 35 and class1 American Society of Anesthesiologists physical status classification system. Exclusion criteria will be: having underlying disease, fetal distress, having multiple pregnancies, non cephalic presentation and using ephedrine during surgery, fetal anomaly and after birth. Women will be assigned to two groups consist of 50 persons in each. In first group after regional anaesthesia, 40 % oxygen by facial mask will be administered and the second group will be let breath in the room air condition. Before and after oxygen therapy o2 saturation of mothers will be measured, after birth the umbilical cord will be clamped and venous blood cord will be sent for laboratory analysis. The apgar score will be documented and results will be statistically compared between study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103011107N5
Registration date:2011-04-26, 1390/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Tajea Jadery
Name of organization / entity
Jundi shapur university
Country
Iran (Islamic Republic of)
Phone
-
Email address
research@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour Medical University
Expected recruitment start date
2010-06-28, 1389/04/07
Expected recruitment end date
2011-02-02, 1389/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of mother oxygen therapy on neonate’s umbilical vein blood Gas after cesarean section under spinal anaesthesia.
Public title
Determination of mother oxygen therapy on neonate’s umbilical vein blood Gas after cesarean section under spinal anaesthesia.
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria : elective cesarean, full term peregnancies, BMI<35, ASA class I, single pregnancy.
exclusion criteria : Maternal hypotension, fetal distress, fetal anomaly after birth, need for ephedrin administration.
Age
From 17 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ahwaz Jondishapur University of Medical Sciences
Street address
Golestan bolvar,Ahwaz
City
Ahvaz
Postal code
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
ETh087
Health conditions studied
1
Description of health condition studied
Anaesthetics and therapeutic gases
ICD-10 code
Y48.5
ICD-10 code description
Therapeutic gases
Primary outcomes
1
Description
O2 sat Of umblical vein
Timepoint
immediately after birth and only one time
Method of measurement
by useing ABG analyser
Secondary outcomes
1
Description
po2
Timepoint
immediately after birth and only one time
Method of measurement
by ABG analyser
Intervention groups
1
Description
case group: oxygen 4 liters per minute -duration: since starting of anesthesia untill termination of surgery- method: by facial mask
Category
Treatment - Other
2
Description
control group: no intervention was done-using air room
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr Afshin Mokfi, Resedent Of Anaesthesia
Street address
Emam Hospital, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Dr Mostafa Feghhi, Vice-Chancellor For Research
Street address
Vice-Chancellor For Research, Ahvaz Jundishapour University of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Science
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
Ahvaz Jundishapour Medical University
Full name of responsible person
Dr Reza Akhoundzade
Position
Assistant professor of Anaesthesia
Other areas of specialty/work
Street address
Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
Rezaakh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour Medical University
Full name of responsible person
Dr Fatemeh Javaher forooshzadeh
Position
Assistant professor of Anaesthesia
Other areas of specialty/work
Street address
Emam Khomeine Hospital,Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 2922
Fax
Email
F_Javaherforoosh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapour University Of medical sciences
Full name of responsible person
Afshin Mokfi
Position
Resident of Anaesthesia
Other areas of specialty/work
Street address
Ahvaz Emam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 2922
Fax
+98 61 1392 1257
Email
Afshinmokfi@yahoo.com; Mokfi.a@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)