This study aims to investigate the effectiveness of nitrous oxide on pain of labor contractions and duration of Labor. The patients will be randomized to receive either a pre-prepared mixture of nitrous oxide and oxygen or only oxygen by a coin. Study drugs will start as early as the onset of pain with each contraction. The patient herself administrate gases via a face-mask which enables the patients to breathe fresh gas in each inspiration. The gas administration will be continued to the end of contraction pain at which the patient breathed the room air. Variables such as SaO2, blood pressure, pain, duration of labor and side effects will be record. Descriptive and interracial statistical analysis the data in the two groups will compare. Using SPSS version 16 data will analyze with p<0.05.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060210426N2
Registration date:2014-10-10, 1393/07/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Entonox on Labor Pain and Outcome of Delivery among Primi-Parrous Women Reffered to Atieh Hospital in Hamadan, 2014
Public title
The Effect of Entonox on Labor Pain and Outcome of Delivery among Primi-Parrous Women Reffered to Atieh Hospital in Hamadan, 2014
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: full term pregnant women; single pregnancy; primiparous; aged between 18-35 years old; vertex presentation; normal pelvic and no stimulation before study.
Exclusion criteria: having a systematic chronic diseases e.g. hypertension, diabetes, asthma, vaginal bleeding; twin pregnancy; multiparous and stimulation before study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
2901/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Labor
ICD-10 code
O80.0
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Relief of Labor pain
Timepoint
Initial, after one hour, after two hours, after three hours, after four hours
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Duration of labor
Timepoint
Initial, after one hour, after two hours, after three hours, after four hours
Method of measurement
Duration of labor per hour
Intervention groups
1
Description
After completing consent form by participants, The patients will be randomized to receive either a nitrous oxide (Entonox) or oxygen by a coin. In the intervention group Entonox gas will be started as early as the onset of pain with each contraction. The patient herself will administrate Entonox gas via a face-mask which enables the patients to breathe fresh gas in each inspiration. The gas administration will continue to the end of contraction pain at which the patient breathed the room air. Variables such as SaO2, blood pressure, pain, duration of labor and side effects will record.
Category
Treatment - Drugs
2
Description
In control group the oxygen will be started as early as the onset of pain with each contraction. The patient herself will administrate Oxygen gas via a face-mask which enables the patients to breathe fresh gas in each inspiration. The gas administration will continue to the end of contraction pain at which the patient breathed the room air. Variables such as SaO2, blood pressure, pain, duration of labor and side effects will record.