Protocol summary

Summary
This study was randomized clinical trial that was no blind study.Aim of study is ‎comparison of labor phases in painless delivery with epidural analgesia and ‎Entonox ‎administration. This study was conducted on 90 pregnant women ‎referred to Taleghani ‎Hospital in Arak, Iran. Inclusion criteria: primigravida ‎women; ‎singleton pregnancies; term pregnancy of 37 to 42 weeks; no medical ‎‎diseases; cervical dilation of 3 to 4 centimeter.Exclusion criteria: multiparous; ‎multiple pregnancy; ‎Preterm labor; Post-term labor. The first group (n=30) ‎received epidural analgesia with injection ‎of 0.125 percent Marcaine and ‎Fentanyl (5 micro gram). The second group (n=30) received general analgesia ‎with Entonox gas. In this ‎study, the third group consisted of 30 pregnant women ‎who were considered as control ‎subjects receiving no medication for labor pain ‎relief.Fetal heart rate was controlled every ‎‎15 minutes, and the duration of each ‎labor phase was accurately calculated in minutes. ‎With regards to labor progress, ‎cervical examination was performed every two hours ‎until full dilation of the ‎cervix. This process continued until the infant was born, and the ‎delivery was ‎complete. Finally, neonatal Apgar scores were recorded in prepared forms ‎by ‎residents of gynecology.‎Comparison of the study groups was performed in terms ‎of the duration of the first and ‎second phases of labor, frequency of cesarean ‎delivery, neonatal Apgar scores, and ‎prevalence of postoperative complications ‎‎(e.g., headache, nausea, vomiting, and ‎backache).‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051820258N9
Registration date: 2016-11-17, 1395/08/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-17, 1395/08/27
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 of Arak University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of labor phases in painless delivery with epidural analgesia ‎and Entonox
Public title
Clinical trial comparison of labor phases in painless delivery with epidural analgesia ‎and Entonox
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primigravida women; ‎singleton pregnancies; term pregnancy of 37 to 42 weeks; no medical ‎diseases; cervical dilation 3 - 4 centimeterv Exclusion criteria: multiparous; multiple pregnancy; Preterm labor; Postterm labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
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
Randomize by Random Number Table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Postal code
848176941
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90-116-3

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Fetal heart rate
Timepoint
every 15 minute
Method of measurement
count

2

Description
Cervix dilatation
Timepoint
every 2 hours
Method of measurement
centimeter

3

Description
Apgar
Timepoint
after operation
Method of measurement
Apgar scale

4

Description
complications after delivery
Timepoint
after operation
Method of measurement
question

Secondary outcomes

empty

Intervention groups

1

Description
The third group consisted of 30 pregnant women who were considered as control ‎subjects receiving no medication for labor pain relief‎
Category
Treatment - Other

2

Description
The first group (n=30) received epidural analgesia with injection of 0.125 percent Marcaine and ‎Fentanyl (5 micro gram).‎
Category
Treatment - Other

3

Description
The second group (n=30) received general analgesia with Entonox gas‎.
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 of 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 of 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
848176941
Phone
+98 86 3222 2003
Fax
Email
alikamaliir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medicine department
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
848176941
Phone
+98 86 3222 2003
Fax
Email
alikamaliir@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
Dr Alireza Kamali
Position
Assistant Anesthesia
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
848176941
Phone
+98 86 3222 2003
Fax
Email
alikamaliir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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