The purpose of the present study is to compare the effect of entonox and oxygen on labor pain and labor progress.
Design: A randomized clinical trial was performed on 120 nulliparas pregnant women who had been admitted in the labor ward of Akbarabadi Teaching Hospital for termination of pregnancy and labor pain in the active phase of labor.
Setting and conduct: The patients were randomly assigned into the two groups of entonox ( case group) and oxygen group ( control group)( each groups were 60 women).
Participants: Inclusion criteria include: term singleton pregnancy, cephalic presentation and appropriate pelvis. Exclusion criteria are: any systemic disorder like asthma; hypertension; diabetes; multiparity; any sign of fetal distress and fetal death; any vaginal bleeding more than labor show; and placenta previa( low risk pregnancy). Intervention: Case group ( group A) were women who received entonox during active phase of labor and group B ( control group) were women who received oxygen. Main outcomes: Pain was evaluated using Visual Analogue Scale( VAS). Duration of the active phase and second stage of labor and also the total duration of labor and pain and adverse effects were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207182624N9
Registration date:2013-01-09, 1391/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-09, 1391/10/20
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
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
Comparison between entonox and oxygen on lowering labor pain and the progress of labor
Public title
lowering labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: term singleton pregnancy; cephalic presentation and appropriate pelvis.
Exclusion criteria are: any systemic disorder like asthma; hypertension; diabetes; multiparity; any sign of fetal distress and fetal death; any vaginal bleeding more than labor show; and placenta previa ( low risk pregnancy).
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Keshavarze Boulvard, Ghods Cross.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90-7214
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
o99-o00 ،
ICD-10 code description
Pregnancy,childbirth and the puerperiumو Single spontaneous delivery
Primary outcomes
1
Description
Labor pain
Timepoint
30 minutes
Method of measurement
VAS
Secondary outcomes
1
Description
duration of labor
Timepoint
From the beginning of the active phase of labor till full dilatation ( active phase of the first stage) and from full dilatation ( 10 cm) till delivery of fetus( second stage )
Method of measurement
Minute
Intervention groups
1
Description
using entonox; the patients was taught to put the mask closely on their noses and breath continuously up to the end of uterine contraction and remove the mask between the contractions. During entonox using, it was temporarily discontinued in the occurrence of the side effects like nausea, vomiting, dizziness. This way was continued from cervical dilatation of 4-5 cm till full dilatation. Entonox is a mixture of 50% oxygen and 50% N2O.
Category
Treatment - Drugs
2
Description
using oxygen ; the patients was taught to put the mask closely on their noses as soon as contraction was begun and breath continuously up to the end of uterine contraction and remove the mask between the contractions. This way was continued from cervical dilatation of 4-5 cm till full dilatation. Oxygen is a 100% oxygen .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi Street, Molavi Cross.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Tehran University of Medical Sciences.
Full name of responsible person
Dr. Fotuhi
Street address
Keshavarz Boulevard , Ghods Cross.
City
Tehran
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 , Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD, Professor
Other areas of specialty/work
Street address
Molavi street, Molavi Cross
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD, professor
Other areas of specialty/work
Street address
Molavi street, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD, professor
Other areas of specialty/work
Street address
Molavi street, Molavi Cross
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)