Objective: Comparison of analgesic effect of inhaling Entonox alone and in combination with dexamethasone in labor. Design: In this interventional study, 90 pregnant women who are candidates for natural childbirth will be selected and divided into two groups using block randomization method (n=45 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen. Inclusion criteria: Over 37 weeks pregnancy, first or second pregnancy and singleton. Exclusion criteria: Malpresentation of fetus and Macrosomia. Setting and intervention: Upon starting the active phase of labor first group will receive face mask of entonox at the beginning of uterine contractions and continue deep inspirations in times when there is pain and cramps and the placebo (Distilled water, 2 cc, Irandaroo Co., once) will be administered intravenously.The second group will receive Entonox (like the first group) with 8mg intravenous dexamethasone (once, 2 cc, Irandaroo Co.) injection. Outcomes measure: Parturient pain score will evaluate according to the VAS score once before any analgesic administrations and two times after (30 and 60 min) analgesic administrations using a structured questionnaire and a subjective labor pain scale (visual analogue scale). Also apgar scores at 1 and 5 minutes will record using a apgar test questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012323559N8
Registration date:2017-03-24, 1396/01/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-24, 1396/01/04
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of inhaling Entonox alone and in combination with dexamethasone in labor
Public title
Labor pain relief with Entonox
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Over 37 weeks pregnancy, first or second pregnancy, singleton. Exclusion criteria: Malpresentation of fetus، Macrosomia.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
5615783134
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.ARUMS.REC.1395.90
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O80, O84
ICD-10 code description
Delivery
Primary outcomes
1
Description
pain
Timepoint
Before analgesic administrations and two times (30 and 60 min) after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar test
Intervention groups
1
Description
Face mask of entonox at the beginning of uterine contractions and continue deep inspirations in times when there is pain and cramps and intravenous placebo (Distilled water, 2 cc, Irandaroo Co., once)
Category
Treatment - Drugs
2
Description
Face mask of entonox at the beginning of uterine contractions and continue deep inspirations in times when there is pain and cramps and 8mg intravenous dexamethasone (2 cc, IrandarooCo., once)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Dr. Fatemeh Hashemi
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
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, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Fateme Hashemi
Position
Gynecology Asisstant
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Fax
Email
Fatemehhashemigyn1392@ yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Rogaeh Dargahi
Position
Gynecologist
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Fax
Email
doctor darghagi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Hashemi
Position
Gynecology Asisstant
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Postal code
Phone
00
Fax
Email
Fatemehhashemigyn1392@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)