Aim of this study is comparison the Apgar score and incidence of cesarean in women undergoing spinal and epidural analgesia during painless delivery methods. This study is clinical trial and single blind. We will enter 126 pregnant women with gestational age 37-42 weeks. All women is pregnant and singleton pregnancy and primigravide. We will assign pregnant women in two groups (epidural analgesia and spinal analgesia). We will epidural analgesia in first group. We will spinal analgesia in second group. We check dilatation in cervix and uterus contraction before delivery. We check incidence cesarean and Apgar in fetus and arterial blood gas after birth. We will send sample of neonatal arterial blood gas (HCO3, PH, po2, co2) to laboratory after delivery.
Inclusion criteria: pregnant women undergoing labor analgesia referred to Taleghani Hospital in Arak; prime gravid; ASA I and II; gestational age 37-42 week; singleton pregnancy
Exclusion criteria: sensitivity to local drugs and narcotics; failure in painless childbirth; ASA class III and IV; patients with mental disorders such as depression, anxiety; patients with gastrointestinal disorders; patients with sleep disorders related to premenstrual syndrome; any use of tranquilizers and sleeping pills
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050920258N46
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Arak University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Apgar score and incidence of cesarean in women undergoing spinal and epidural analgesia during painless delivery methods
Public title
incidence of cesarean in women with spinal and epidural analgesia method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women undergoing labor analgesia referred to Taleghani Hospital in Arak; prime gravid; ASA I and II; gestational age 37-42 week; singleton pregnancy
Exclusion criteria: sensitivity to local drugs and narcotics; failure in painless childbirth; ASA class III and IV; patients with mental disorders such as depression, anxiety; patients with gastrointestinal disorders; patients with sleep disorders related to premenstrual syndrome; any use of tranquilizers and sleeping pills
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
patients and analyzer are blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
IR.ARAKMU.REC.1395.392
Health conditions studied
1
Description of health condition studied
painless delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
2
Description of health condition studied
spinal and epidural anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy
Primary outcomes
1
Description
dilatation in cervix
Timepoint
before delivery every 2 hours
Method of measurement
clinical examination
2
Description
uterus contraction
Timepoint
before delivery every 1 hours
Method of measurement
clinical observation
3
Description
incidence cesarean
Timepoint
after delivery
Method of measurement
count
4
Description
Apgar
Timepoint
one and fifth minute after delivery
Method of measurement
Apgar scale
5
Description
arterial blood gas
Timepoint
after delivery
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: epidural block for delivery
Category
Treatment - Other
2
Description
Intervention group: spinal analgesia for delivery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani hospital, Emam Khomeini street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences