The aim of this study is to determine the side effects of entonox on pregnant women during labor to reduce patient demand cesarean section. This study is a single blind controlled randomized clinical trial on term primiparus pregnant women in active phase of labor without any medical disease or obstetrical complications excluded that refused to participate in study .The number of participants was 178 patients in case & control groups witch entonox & oxygen was administrated respectively. Thereafter parameters such as evidence of placental abruption before 7 after delivery, mechonium passage, APGAR score, symptoms such as nausea & vomiting ,drowsiness, vertigo, dryness of mouth & tongue paresthesia & the amount of post partum bleeding number of used pads 6 hours after delivery & drop of Hb 6 hours of delivery were investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012035299N1
Registration date:2011-11-04, 1390/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-04, 1390/08/13
Registrant information
Name
Seideh Saideh Asadi
Name of organization / entity
Hamedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
s-asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2011-01-13, 1389/10/23
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of side effects of entonox on mother & new born in primiparus pregnant women
Public title
Side effects of entonox on mother & new born
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :primiparus;term pregnancy(37-42wks);active phase of labor(cervical dilatation of 3-4 cm);no medical disease or obstetrical complication in mother & fetus
Exclusion criteria :women who refuse to participate in this study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
178
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
Hamedan university of medical sciences
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
آHamedan
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
16/35/9/163358/پ
Health conditions studied
1
Description of health condition studied
delivery related complications
ICD-10 code
o67.8
ICD-10 code description
Excessive intrapartum haemorrhage
Primary outcomes
1
Description
placental abruption
Timepoint
during intervention
Method of measurement
observation
2
Description
accelerated labor
Timepoint
during intervention
Method of measurement
observation
3
Description
neonatal APGAR score minute 1&5
Timepoint
1&5 minutes after delivery
Method of measurement
observation
4
Description
Final route of delivery
Timepoint
during intervention
Method of measurement
observation
5
Description
fetal meconium passing
Timepoint
during intervention
Method of measurement
observation
6
Description
maternal complications
Timepoint
6 hours after delivery
Method of measurement
question sheet
7
Description
used pads
Timepoint
6 hours after itervention
Method of measurement
question sheet
8
Description
Hb
Timepoint
Before & 6 hours after intervention
Method of measurement
grams per desiliteres
Secondary outcomes
empty
Intervention groups
1
Description
In the case group entonox was administrated in active phase of labor & the patient inspirited in the mask 30 seconds before beginning of labor pain.
Category
Treatment - Drugs
2
Description
In the control group oxygen was administrated in active phase of labor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan's Fatemieh Hospital
Full name of responsible person
Dr. Shahla Nasrolahi
Street address
Hamadan's Fatemieh Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan's Fatemieh Hospital delivery ward
Full name of responsible person
Dr. Shala Nasrolahi
Street address
Hamadan's Fatemieh Hospital
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan's Fatemieh Hospital delivery ward
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shala Nasrolahi
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
sh_nasrolahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shahla Nasrolahi
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
sh_nasrolahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Dr. Shahla Nasrolahi
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)