Comparison the effect of entonox gas and spinal on mothers' satisfaction and newborn's apgar score Analgesia in Labor. A randomized clinical trial study
A comparison of the effects of ENTONOX inhalation and spinal anesthesia on mothers' satisfaction and newborn's Apgar score in painless delivery
Design
Clinical trial with a control group, double-blind, randomized, phase 2 on 52 patients. WinPepi software will be used for randomization.
Settings and conduct
This study will be conducted as a double-blind clinical trial study at Al-Zahra Medical Center during 2024.
Participants/Inclusion and exclusion criteria
Pregnant women with dilatation of at least 5 cm
Intervention groups
-In the first group with Entonox gas, the mothers were first introduced to the Entonox capsule and mask and how to use it was explained to them.
-In order to perform spinal analgesia, first a complete history will be taken from the patient, then a physical examination will be performed in terms of any changes in the anatomy of the spine, then the patient's vital signs including blood pressure, heart rate, breathing rate before and after spinal anesthesia will be checked.
-In the third group, which is the control group, no intervention will be done and pregnant women will give birth naturally without any intervention.
Main outcome variables
Mothers' satisfaction and newborn's Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231202060247N1
Registration date:2024-04-17, 1403/01/29
Registration timing:registered_while_recruiting
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
nasibeh roozbeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 160 6652
Email address
nasibe62@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of entonox gas and spinal on mothers' satisfaction and newborn's apgar score Analgesia in Labor. A randomized clinical trial study
Public title
Comparison the effect of entonox gas and spinal on mothers' satisfaction and newborn's apgar score Analgesia in Labor. A randomized clinical trial study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with dilatation of at least 5 cm
Exclusion criteria:
Lack of consent to participate in the study
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly with a ratio of one to one
Patients with the help of random blocks of four created by the computer (Win Pepi 11.65 software) by an anesthesiologist who does not participate in the project through the list of eligible patients who have given informed consent and the sequence of randomization blocks in a ratio of 1:1 to One of the two groups of Antonox and Spinal are assigned
Blinding (investigator's opinion)
Double blinded
Blinding description
Spinal block and analgesia with Entonox will be performed by an anesthesiologist .Gynecologist is present at the patient's bedside when the midwife opens the delivery set and when the patients are not receiving medication. Thus, the patient and the gynecologist are unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of HUMS
Street address
Imam Hossein Blvd
City
Banadarabbas
Province
Hormozgan
Postal code
7919693116
Approval date
2023-12-02, 1402/09/11
Ethics committee reference number
IR.HUMS.REC.1402.340
Health conditions studied
1
Description of health condition studied
زایمان
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Apgar
Timepoint
Labor and postpartum
Method of measurement
Verbal rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Mothers are first introduced to Entonox capsules and mask and how to use it is explained to them. When the uterus starts to contraction, put the mask on the face of mother and start breathing Entonox gas, and after finishing the contraction, remove the mask from the face and breathe in the room air until the next contraction and put the mask on the face again
Category
Treatment - Drugs
2
Description
Intervention group 2: In order to perform spinal analgesia, first a complete history will be taken from the patient, then a physical examination will be performed in terms of any changes in the anatomy of the spine. After establishing a suitable intravenous line, 10 ml/kg of normal saline It is injected intravenously for 15-30 minutes, then the patient is placed in a sitting position and using a 25 size needle (B.Brown company) through the L3-L4 or L4-L5 lumbar vertebrae, fentanyl narcotic with a dose of 25 macro anesthesia will be done .
Category
Treatment - Drugs
3
Description
Control group 1: no intervention will be done and pregnant women will give birth by normal delivery method without any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan University of Medical Sciences
Full name of responsible person
Shiva Alizadeh
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
41446-54829
Phone
+98 13 3336 9326
Email
Shiva.alizadeh51@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.Vali Alipour
Street address
Pardis Educational Complex-Nebubat Township- إeginning of Imam Hossein Blvd-Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3128 1680
Email
Research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?