Protocol summary

Study aim
Comparison of the Effectiveness of Epidural Anesthesia with two different combination, Bupivacaine Plus Fentanyl versus Bupivacaine plus Meperidine in Duration of Labor and Cesarean Section Rate
Design
In this study, 264 eligible women who are candidates for normal delivery and are included in the study and will be randomly divided into two groups after obtaining informed consent.
Settings and conduct
This study will be conducted on women referring to Arash Women's Hospital. Once the informed consent has been achieved, randomization will be performed. The random allocation list is only available to the group's epidemiologist and participants and researchers as well as the statistics counselor will be unaware of how the participants are assigned. For subjects after infusion of 7 cc / kg of ringer serum after confirmation of the patient entering the active phase of the first stage of labor, appropriate monitoring is performed and patient will be placed in a sitting position. After desensitizing the needle insertion place with two to three milliliters of lidocaine 2%, 18-gauge epi-dural needle will be inserted by using the loss of resistance technique. after a test dose with 3 ml of lidocain plus epinephrine, Epidural Anesthesia will be done with bupivacaine plus fentanyl in the first group and with bupivacaine plus meperidine in the second group and the catheter will be fixed in the epidural space. The patient then will be place in sleeping position and will be obsrved untill delivery .if be necessary, a vaginal examination is performed in the lithotomy position.
Participants/Inclusion and exclusion criteria
Patients participating in the study must be aged between 18 and 40 years old, tendency to painless delivery, ASA Class I, and II-BMI <35. Women with obstetrical or medical contraindication (mitral valve stenosis) for NVD are not included in the study.
Intervention groups
In the first group, 15 cc of bupivacaine 125 % with 50 μg fentanyl and in the second group 15 cc bupivacaine 125 % with 25 mg of meperidine is injected into the epidural space and the catheter is fixed in the epidural spaces.
Main outcome variables
- Duration of the active phase of labor - Duration of the second stage of labor - Score of Pain Relief - Cesarean section Rate - Apgar Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170917036227N1
Registration date: 2018-01-14, 1396/10/24
Registration timing: registered_while_recruiting

Last update: 2018-01-14, 1396/10/24
Update count: 0
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
mvahid@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Epidural Anesthesia with Two Different Combination, Bupivacaine plus Meperidine versus Bupivacaine Plus Fentanyl in Duration of Labor and Cesarean Section Rate
Public title
Effect of Epidural Anesthesia on the Progression of Labor by Bsing Meperidine Compared to Fentanyl
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients tendency for Painless labor Age range between 18 to 40 years BMI smaller than 35 ASA Class I, II
Exclusion criteria:
Obstetrics Contraindication for normal delivery Spinal Deformity Coagulopathy Subacute illness Medical Contraindication for natural delivery like Mitral valve stenosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 264
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 264 people, with 132 people in each group. Block randomization method was designed by epidemiologist using stata version 13 software. The number of blocks considered is 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 264 sequences of treatments will be written accordingly, and then the cards will be placed in sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When an anesthesiologist announces the eligibility of a patient, the methodologist will provide the anesthesiologist with the envelope. The analgesia method is selected based on the type mentioned in the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods st, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.427

Health conditions studied

1

Description of health condition studied
epidural anesthesia during labor and delivery
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery

Primary outcomes

1

Description
Apgar Score
Timepoint
after intervention
Method of measurement
Scoring according to apgar score checklist

2

Description
Duration of the active phase of labor
Timepoint
after intervention
Method of measurement
minutes and hours

3

Description
Duration of the second stage of labor
Timepoint
after intervention
Method of measurement
minutes and hours

4

Description
Score of Pain Relief
Timepoint
During Labor
Method of measurement
Visual Scale

5

Description
Cesarean section Rate
Timepoint
after intervention
Method of measurement
Checklist

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg fentanyl
Category
Treatment - Other

2

Description
In the second group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg meperidine
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Dr Fatemeh Jafarzadeh
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
Dr.fatemeh.gafarzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Jafarzadeh
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Women's Hospital, Rashid Ave,Tehranpars, Reslat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
dr.fatemeh.gafarzadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Vahid Dastjerdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
mvahid@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Jafarzadeh
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash women's hospital, Rashid Ave,Tehranpars, Reslat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
dr.fatemeh.gafarzadeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
because we plan to use our data in another studies thus we dont intresting to sharring that
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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