The aim of this study was to compare two methods of labor with epidural and spinal analgesia in pregnant women in Taleghani Hospital in Arak.In this study, 90 patients were randomly divided into three groups epidural analgesia in labor, spinal analgesia in labor and control group. Inclusion criteria: All pregnant women between 37-42 weeks; ASA class I and II; prim gravid; cervical dilation 3 -4 cm; absence of fever and systemic infection or other disease; lack of coagulopathy; age 18-40. Exclusion criteria: failure epidural and Spinal analgesia; sensitivity to opioids; mothers with gestational age below 37 weeks; mothers with multiple fetus. Cervix dilation record in delivery. Vital signs, oxygen saturation, blood pressure and breathing rate maternal and fetal heart rate record every 15 minutes .After delivery, researcher records Apgar score , fetal heart rate and vital signs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050420258N8
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
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
Arak University Of Medical Science
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison stage of vaginal delivery in painless labor with epidural &spinal analgesia
Public title
Comparison stage of vaginal delivery in painless labor with epidural &spinal analgesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All pregnant women gestational age between 37-42 weeks; ASA class I and II; primigravida; dilatation of cervix 3-4 cm; lack of systemic infection or fever and other diseases; lack of sensitivity opioid; absence of coagulopathy; age 18-40
Exclusion criteria: ASA class two and three; failure epidural and spainal anasthesia; sensivity to opioid; mothers with gestational age below 37 weeks; mothers with more than one fetus fetus
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Postal code
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.ARAKMU.REC.1394.297
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.8
ICD-10 code description
Other single spontaneous delivery
Primary outcomes
1
Description
oxygen saturation
Timepoint
every 15 minute
Method of measurement
oxymeter
2
Description
heart rate
Timepoint
every 15 minute
Method of measurement
count
3
Description
respiratory rate
Timepoint
every 15 minute
Method of measurement
count
4
Description
Fetal heart rate
Timepoint
every 15 minute
Method of measurement
sony cate
5
Description
Labor progress
Timepoint
every 15 minute
Method of measurement
centimeter
6
Description
Apgar
Timepoint
After delivery
Method of measurement
Apgar scale
Secondary outcomes
empty
Intervention groups
1
Description
The first group of 30 pregnant women have an epidural.
Category
Diagnosis
2
Description
In the control group of 30 pregnant women delivery without anything.
Category
Diagnosis
3
Description
In the second group involved 30 pregnant women receiving spinal anesthesia.
Category
Diagnosis
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
Full name of responsible person
Dr Mohammad Rafiee
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
alikamali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
alikamali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Yazdan Ghandi
Position
student of medicine
Other areas of specialty/work
Street address
Arak medical science university
City
Arak
Postal code
848176941
Phone
+98 912 383 3712
Fax
Email
fa.farokhi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)