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Comparison of the Fetal Heart Rate changes between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery

Protocol summary

Study aim
Comparison of the Fetal Heart Rate changes between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery
Design
One hundred healthy mother with term and singleton pregnancy candidate for NVD with neuroaxial analgesia, entered the study after obtaining written informed consent, will be placed respectively and randomly into two groups of 50 (combined or epidural).
Settings and conduct
Pregnant women in Taleghani hospital in Tabriz, are randomly and blinded assigned into two groups. Two technicians who are blind to the analgesia record the fetal heart rate, fetal motion and then the Apgar score.
Participants/Inclusion and exclusion criteria
Entrance criteria: Ability to have a normal vaginal delivery The delivery to be in the active phase. Exit criteria: Missing consent , Inability of the pregnant to remain motionless while doing work, Coagulation disorder, Increased intracranial pressure, Local infections. History of sensitivity, Acute lesions of the CNS, Hemodynamic Disorders, Cardiovascular Diseases, Embryonic distress, GA <37 w, Abnormal fetal presentations, History of C/S - BMI> 40
Intervention groups
1. First intervention group (Epidural analgesia group): First for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine are used. Then as a preservative dose 6 cc / h from the solution is injected through the catheter. 2. Second intervention group (Combined analgesia group): First 1.5ml of the same solution is injected and then the epidural block will be performed using the same method of epidural group.
Main outcome variables
Reducing labor pain and reducing C/S frequency due to maternal fears of normal labor pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040241N1
Registration date: 2018-09-22, 1397/06/31
Registration timing: retrospective

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Nabiha Al Darir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3441 1230
Email address
nonitahasan@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
empty
Scientific title
Comparison of the Fetal Heart Rate changes between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery
Public title
Effects of Epidural and Combined Analgesia on the Fetal Heart Rate.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to have a normal vaginal delivery Existence of labor pain and the delivery is in the active phase. Pregnant mother wants to reduce labor pain itself. Consent of the patient and her husbend.
Exclusion criteria:
Missing consent of pregnant woman or spouse. Inability of the pregnant to remain motionless while doing work(e.g. Parkinson disease). Coagulation disorder Increased intracranial pressure (SOL). Local infections at the puncture site History of sensitivity to analgesics and other medication used in this investigation Acute lesions of the CNS Hemodynamic Disorders (e.g. hypotension or Hypovolemia). Cardiovascular Diseases that reduce the cardiac output Embryonic distress. GA <37 w Abnormal fetal presentations History of C/S or any surgery on the uterus BMI> 40
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The pregnant woman in this study gives consent to the Analgesia while she is blind from its type. A trained Anesthesia technician and an midwife who are blinded from the analgesia type monitor and record the fetal heart rate, fetal motion and then the Apgar score.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Office of the University of Medical Sciencesو Golgast Streetو Azadi Avenueو Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615739
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.TBZMED.REC.1397.240

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fetal heart rate
Timepoint
5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus
Method of measurement
With the use of the fetal monitor

2

Description
Fetal motion
Timepoint
5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus
Method of measurement
With the use of the fetal monitor

3

Description
Apgar scor
Timepoint
After the delivery at the minute 1 and 5
Method of measurement
calculating

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (Epidural analgesia group): The neuroaxial block is performed with epidural needle number 18 G . First, for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine are used. Then as a preservative dose 6 cc / h from this solution is injected through the catheter.
Category
Treatment - Drugs

2

Description
Intervention group (Combined spinal-epidural analgesia group): First with a spinal needle 25G, the spinal block with 1.5ml of the same solution is performed and then the epidural block will be performed using the same method of epidural group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital in Tabriz
Full name of responsible person
Dr. Hojjat Pourfathi
Street address
Railway square، Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
000
Phone
+98 41 3442 4423
Fax
+98 41 3442 4882
Email
taleghani.hos@tbzmed.ac.ir
Web page address
https://taleghanihosp.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. jouyban
Street address
Central Office of the University of Medical Sciences, Golgast Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
000
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nabiha aldarir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shayan mehr dorm, eqbal aazar ave, Resalat Street
City
Tabriz
Province
East Azarbaijan
Postal code
5178757395
Phone
+98 41 3441 1230
Email
nonitahasan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nabiha aldarir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shayan mehr dorm, eqbal aazar ave, Resalat Street
City
Tabriz
Province
East Azarbaijan
Postal code
5178757395
Phone
+98 41 3441 1230
Email
nonitahasan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nabiha aldarir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shayan mehr dorm, eqbal aazar ave, Resalat Street
City
Tabriz
Province
East Azarbaijan
Postal code
5178757395
Phone
+98 41 3441 1230
Email
nonitahasan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences
When the data will become available and for how long
We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences
To whom data/document is available
We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences
Under which criteria data/document could be used
We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences
From where data/document is obtainable
Central Library of Tabriz University of Medical Sciences and Faculty of Medicine
What processes are involved for a request to access data/document
We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences
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