Objectives: To determine the effect of inhaled entonox with and without spinal anesthesia on maternal and neonate outcomes in vaginal delivery.
Study design: After obtaining informed consent of seventy five primigravid parturients requesting to select one of the following three methods during labor in vaginal delivery. Inhale entonox gas, entonox with spinal analgesia or non-analgesia labor.
Setting and conduct: Parturients in the first group receive the entonox gas by commencement of active phase with cervix dilatation 3-4cm until 9-10 cm. Second group, receive the entonox with cervix dilatation 3-4cm until 5-6cm and then entonox is interrupted and they receive spinal anesthesia. Third group do not receive any analgesia treatment during labor.
Participants including major eligibility criteria: The inclusion criteria including aged between 18 and 35; primigravid with pregnancy ≥37 weeks gestation; in the active phase of labor with cervical dilation of 3-4 cm. Exclusion criteria including contraindication for vaginal delivery or spinal analgesia; multiple pregnancies; use of sedative drugs; pregnancy related disease and fetal malpresentation.
Intervention: Parturients in the first group received entonox and in the second group received entonox and then intrathecal injection of 0.2 ml of bupivacaine (10 mg) plus 0.2 ml mepridine at L4-L5.Third group don’t receive analgesia treatment.
Main outcome measures (variables): Duration of the first, second and third stage of labor, perineal laceration, labor pain, maternal blood pressure, birth weight and Apgar scores were recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111218109N2
Registration date:2016-05-29, 1395/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Hamdollah Delaviz
Name of organization / entity
Yasuj University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 2223 5135
Email address
delaviz.h@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Merical Sciences, Vice chancellor for research
Expected recruitment start date
2015-04-03, 1394/01/14
Expected recruitment end date
2017-04-03, 1396/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the Effect of inhaled entonox with and without spinal anesthesia on outcomes painless delivery
Public title
Delivery
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria including aged between 18 and 35; primigravid with pregnancy ≥37 weeks gestation; in the active phase of labor with cervical dilation of 3-4 cm. Exclusion criteria including contraindication for vaginal delivery or spinal analgesia; multiple pregnancies; use of sedative drugs; pregnancy related disease and fetal malpresentation.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical research ethics committees in Yasuj University of Medical Science
Street address
Vice chancellor for research, Yasuj University of Medical Sciences, Mothari street
City
Yasuj
Postal code
7591994799
Approval date
2015-04-03, 1394/01/14
Ethics committee reference number
ir.yums.REC.1394.34
Health conditions studied
1
Description of health condition studied
labour and childbirth
ICD-10 code
080-084, O
ICD-10 code description
delivery, Pregnancy, childbirth and the puerperium, prolong first stage of labour, prolong second stage of labour
Primary outcomes
1
Description
Duration of the first, second and third stage of labor
Timepoint
labor
Method of measurement
chronometer
2
Description
perineal laceration
Timepoint
after delivery
Method of measurement
examination
3
Description
fetal heart rate
Timepoint
fetal heart rate will record in every 15 and 5 minutes in the first and second stage of labor
Method of measurement
sonicaid
4
Description
Apgar scores
Timepoint
Apgar score will record in first minute and 5 minute after delivery.
Method of measurement
examination
5
Description
birth weight
Timepoint
after delivery
Method of measurement
balance
6
Description
labor pain
Timepoint
during labor
Method of measurement
visual analog scale pain
7
Description
maternal blood pressure
Timepoint
blood pressure will measure before delivery and in every 15 minutes during the labor
Method of measurement
manometer
Secondary outcomes
empty
Intervention groups
1
Description
In first group the parturients train to breathing deep entonox gas (nitrous oxide and oxygen, N20+02) in mask whenever she touch or feel uterine contractions by put their hand on abdomen and put mask aside between uterine contractions. They use of entonox with cervix dilatation 3-4cm and effacement ≥40% and put aside at 9-10 cm dilatation with effacement ≥80%.
Category
Treatment - Other
2
Description
Second group receive entonox inhalation by commencement of active phase with cervix dilatation 3-4cm until 5-6 cm and then entonox will interrupted and they receive 500 ml ringer lactate. For achieving spinal analgesia, the intervertebral space of L4-L5 will identify and intrathecal injection dose including 0.2 ml of bupivacaine (10 mg) plus 0.2 ml mepridine (10mg) in two stages with using of spinal needle (27-gauge). In the first stage a third of this compound was injected and the remaining two-thirds will inject 5 minutes later.
Category
Treatment - Drugs
3
Description
Third group do not receive any analgesia treatment during labor
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam sajad hospital
Full name of responsible person
Parastou Rad
Street address
Imam Sajad hospital, Jalil Street
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Abdmohammad Mosavi
Street address
Vice chancellor for research of Yasuj University of Medical Sciences,Yasuj university of Medical sciences, Mothari street
City
Yasuj
Grant name
مقايسه تاثیر روش استنشاقي انتونوكس با و بدون بی حسی نخاعی در پيامد های زايمان بي درد
Grant code / Reference number
ir.yums.REC.1394.34
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Yasuj 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
Yasuj university of Medical sciences,
Full name of responsible person
Hamdollah Delaviz
Position
Associate professor of Anatomy
Other areas of specialty/work
Street address
Department of anatomy, Medical school, Yasuj university of Medical sciences,
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 0290
Fax
+98 74 3323 0290
Email
delavizhamdi83@gmail.com; Delaviz.h@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Hamdollah Delaviz
Position
Associate professor of Anatomy
Other areas of specialty/work
Street address
Department of Anatomy, medical school, Yasuj School of Medicine
City
Yasuj
Postal code
7591994799
Phone
+98 743230290
Fax
+98 743230290
Email
Delaviz.h@yums.ac.ir; delavizhamdi83@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Hamdollah Delaviz
Position
Ph.D in Anatomy
Other areas of specialty/work
Street address
Department of anatomy, Medical school, Shaid Jalil street, .
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 0290
Fax
+98 74 3323 0290
Email
delavizhamdi83@gmail.com, parastou.rad@gmail.com
Web page address
www.yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)