Protocol summary

Study aim
Reducing the pain and suffering of labor, which encourages more mothers to deliver normal labor and reduce the stress of labor pain.
Design
This study is a randomized clinical trial (Randomized clinical trial) that is done in double blinds for all pregnant women referred to Taleghani hospital in Arak who are candidates for normal delivery. In this study, 112 patients with normal delivery were randomly divided into two equal groups of epidural delivery with bupivacaine and rupivacaine.
Settings and conduct
For both groups of pregnant women, a questionnaire asking for demographic information, cesarean section and mean delivery phases is completed.
Participants/Inclusion and exclusion criteria
Entry requirements: single pregnant mothers and vaginal delivery candidates, mothers with grade 1 and grade 2 ASA, mothers between the weeks 42-37 who are perfectly graduated and have an epidural analgesic satisfaction Conditions of failure to enter:failure in the epidural analgesia and pregnant mothers who are candidates for cesarean section for emergency reasons
Intervention groups
After obtaining informed consent, 112 pregnant women will be subjected to natural epidural analgesia (epidural analgesia) with bupivacaine or ropivacaine. After receiving 3-5 cc / kg of crystalloid fluid and placing the required monitoring in Sitting from L3-L4 or L4-L5 space using gage20 needle under epidural analgesia with bupivacaine or rupivacaine, then an epidural catheter is fixed. Patients use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epidermis. For preservative dosage, the combination of marcaine is 125% and fentanyl% 002/0 is used at 6-10 cc / h.
Main outcome variables
Mean of motor blocker, mean of Apgar score of 1 and 5 neonates, mean of use of labor aid tools, mean satisfaction of patients, mean cesarean section, mean duration of second stage of labor, average active period of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180903040936N1
Registration date: 2019-01-05, 1397/10/15
Registration timing: prospective

Last update: 2019-01-05, 1397/10/15
Update count: 0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Narges Anousheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4449 7630
Email address
nargesanousheh1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of painless delivery with epidural analgesia with Bupivacain and Rupivacain in womwn candidating Analgesia labor
Public title
The effect of Bupivacaine and Ropivacaine on labor Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with one fetus Pregnant mothers who are candidates for vaginal delivery (Physiological delivery) Nullipar pregnant mothers are candidates for vaginal delivery Pregnant women referring to Taleghani Hospital with informed consent to participate in the study. Mothers with ASA grade one and two Pregnant mothers between the weeks 37-42 Who are perfectly pregnant Pregnant mothers who are candidates for vaginal delivery, who are satisfied with epidertal analgesia
Exclusion criteria:
Patients in the epidural group who undergo epidural block failure after an epidural analgesia. Pregnant mothers who are candidates for cesarean section for emergency reasons (such as placental abruption, umbilical cord prolapse, etc.).
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table, patients randomly divided into two groups of painless epidural delivery with bupivacaine and rupivacaine.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the anesthetist responsible for the study is aware of the type of study and the studied groups, while the patients are under the epiderdal analgesia and are not aware of the type of injectable drug.َAlso intern is responsible for the plan that is responsible for filling the questionnaire. It is not aware of the type of groups in terms of injectable drugs, and only knows the groups based on A and B, and completes questionnaires on the basis of it.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht, Basij Square, next to Amiralmomenin Hospital, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-09-21, 1397/06/30
Ethics committee reference number
IR.ARAKMU.REC.1397.134

Health conditions studied

1

Description of health condition studied
Epidural analgesia with two drugs, Bupivacaine and Rupivacaine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average cesarean section
Timepoint
After intervention, observing the progression of labor and the occurrence of problems requires intervention
Method of measurement
Examination

2

Description
Average active delivery time
Timepoint
After the intervention, when the cervical dilatation reaches 4 to 8 centimeters
Method of measurement
Examination

3

Description
Average duration of second stage of labor
Timepoint
After the intervention, from the beginning of the full dilation of the uterus until the birth of the baby
Method of measurement
Examination

4

Description
The average satisfaction of the patient
Timepoint
2 hours after intervention
Method of measurement
Based on satisfaction checklist

5

Description
Number of use of labor aid tool
Timepoint
Up to 3 hours after intervention
Method of measurement
Number

6

Description
Mean Apgar score of 1 and 5 minutes
Timepoint
After the intervention, 1 and 5 minutes after childbirth
Method of measurement
Apgar score check list

7

Description
Average motor blocking effect
Timepoint
After intervention, up to 2 hours after childbirth
Method of measurement
Scoring patient in the checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In the first group, after obtaining informed consent, 56 pregnant mothers with natural epidural analgesia (epidural analgesia) are contracted with bupivacaine. The patients received 3-5 cc / kg of crystalloid fluid and placed the necessary monitoring In sitting mode, the L3-L4 or L4-L5 space is inserted into the epidural analgesia using the gauge20 needle, then the epidural catheter is fixed. Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl 002/0 is used at 6-10cc / h.
Category
Treatment - Drugs

2

Description
Intervention group: In the second group, the rupivacaine group, after obtaining informed consent, 56 pregnant mothers will be subjected to oral aphrodisiacs with epidural analgesia (epidural analgesia) with ropivacaine. Patients after taking 3-5 cc / kg of crystalloid fluid and placing sequestered monitoring from L3-L4 or L4-L5 space using gage20 needle under epidural analgesia with rupivacaine and then fix epidural catheter . Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl% 002/0 is used at 6-10 cc / h.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Narges Anousheh
Street address
West Side of Imam Khomeini Street,Next to Gas Co
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
It-taleghani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Basij Square , Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Narges Anousheh
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ashrafi Esfahani Highway
City
Tehran
Province
Tehran
Postal code
1476985574
Phone
+98 21 4449 7630
Fax
Email
nargesanousheh1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Narges Anousheh
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ashrafi Esfahani Highway
City
Tehran
Province
Tehran
Postal code
1476985574
Phone
+98 21 4449 7630
Fax
Email
nargesanousheh1994@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Narges Anousheh
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ashrafi Esfahani Highway
City
Tehran
Province
Tehran
Postal code
1476985574
Phone
+98 21 4449 7630
Fax
Email
nargesanousheh1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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