Entonox take effect on the duration of the active phase of labor and delivery in pregnant women who referred to Ahvaz Imam Khomeini hospital for termination of pregnancy
This clinical trial was performed on 200 pregnant women who were referred for termination of pregnancy to delivery. In study group, Entonox gas was used in delivery. In control group delivery was done without anaesthesia. Mothers from the beginning of the active phase of the study came to study. Pregnant women with systemic disease - women who had narcotics within eight hours - multiple pregnancies - a non-cephalic presentation - head and pelvic disproportion - Poly Alygvhydramnyvs - meconium - fetal distress and ... and those who had complications during labor and induction of labor or cesarean delivery were excluded from the study were required. During the active phase of the second stage of labor and the newborn Apgar score were measured. Entonox adverse events per hour of labor pain and delivery phase and were asked to decrease. Maternal satisfaction was assessed at the end of the delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204079407N1
Registration date:2012-09-29, 1391/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-29, 1391/07/08
Registrant information
Name
Vahide alsadat Torabzade Bafghi
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 2114
Email address
torabzade.v@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Entonox take effect on the duration of the active phase of labor and delivery in pregnant women who referred to Ahvaz Imam Khomeini hospital for termination of pregnancy
Public title
Entonox effect on the duration of the active phase and the delivery
Purpose
Health service research
Inclusion/Exclusion criteria
Pregnant women hospitalized in Imam Khomeini hospital after termination of pregnancy and stabilize their situation, receive and record demographic data and information about the state of pregnancy, pregnant women are literate (in the sense of numbers), the active phase of labor (cervical dilatation 4 having at least 2 to 3 cm and uterine contractions within 10 minutes)were under a gas anesthetic Entonox. Pregnant women with systemic disease - women who had narcotics within eight hours - multiple pregnancies - a non-cephalic presentation - head and pelvic disproportion - Poly Alygvhydramnyvs - meconium - fetal distress and ...Were not enrolled. And those who had complications during labor and induction of labor or cesarean delivery were required, were excluded from the study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ahvaz university of medical science
Street address
Goolestan-ahvaz
City
Ahvaz
Postal code
61335
Approval date
2011-11-12, 1390/08/21
Ethics committee reference number
Eth-316
Health conditions studied
1
Description of health condition studied
Pain and course delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration the active phase of labor
Timepoint
During the intervention
Method of measurement
Hour
Secondary outcomes
1
Description
Labor pain
Timepoint
During the intervention
Method of measurement
Visual Pain Scale
Intervention groups
1
Description
In the active phase of labor in the study group, Entonox combined with 50% O2 and 50% N2O was given to mothers with usage of Restraint method.so the mothers said to put their hand on their abdomen and Upon tightening the abdominal ,soon about 30-40 seconds before the pain begins,Breathe deep and slow the gas and the inhalation continued until the end of pain. inhalation of gas through a mask was with PCA method .
Category
Other
2
Description
In control group, delivery was without Entonox gas or any kind of anesthesia
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital of ahvaz
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research unit of Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Vice Chancellor for Research and Technology Development-Ahvaz university of medical science-Goolestan-Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research unit of Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Vahide alsadat Torabzade
Position
MD
Other areas of specialty/work
Street address
No. 20- Nastaran alley- Shahid Karimi.st - Emam Hasan square- Tmisar Falahi. st - Safaie- Yazd