Comparison of suckling success rate in mothers with analgesia (epidural anesthesia) with normal delivery
Design
Clinical trial with two groups of 150, in parallel, by random sampling method, using randomized software (Rand list online)
Settings and conduct
Comparison of suckling success rate in mothers with analgesia (epidural anesthesia) with normal delivery in the delivery department of Taleghani Hospital in Tabriz
Participants/Inclusion and exclusion criteria
Inclusion criteria: First-born women with single-dose pregnancies
;Pregnancy up to 37 weeks
;Demand for labor with epidural
; Healthy baby
Exclusion criteria: Multicultural women
; Lack of lactation or scientific indication
; Embryonic anomalies or metabolic diseases that make it impossible to breastfeed
; Missing pregnant woman for epidural anesthesia
; APGAR score less than 7
; Asafixy baby
Intervention groups
The intervention group included women with epidural method, receiving bupivacaine 0.12% 125/0% or rupivacaine 0.1-0.2% + fentanyl 51 μg per 10-15 ml volume.
The control group includes women with normal delivery that do not receive intervention
Main outcome variables
Nausea, headache, back pain, respiratory depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160103025821N7
Registration date:2019-06-13, 1398/03/23
Registration timing:prospective
Last update:2019-06-13, 1398/03/23
Update count:0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
Hojjat Pourfathi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
pourfathih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of breastfeeding success rate in mothers under painless delivery by epidural anesthesia with normal vaginal delivery
Public title
success rate in mothers under painless delivery by epidural anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
single baby nollipar woman, Pregnancy up to 37 weeks; Demand for labor with epidural; Healthy baby
Exclusion criteria:
multi-parity; no willing to lactation, Embryonic anomalies or metabolic diseases that make it impossible to breastfeed; no willing to lactation, insatis fact for epidural anesthesia APGAR score less than 7; Asafixy baby
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
All patients were Simple random assigned into two groups using randomized computer data to two treatment groups: (100) Patients in the analgesia group and (100) patients in the control group will be included in the study. Will be grouped by research experts using random numbers tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
The questionnaire is filled in by the midwife and will be recorded by the student (blind).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the research and technology department, Tabriz University of Medical sciences
Street address
Research department, Daneshghah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.TBZMED.REC.1398.131
Health conditions studied
1
Description of health condition studied
Lactation success rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypotension
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
Monitoring, Sphygmomanometer tool
2
Description
Backpain
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
History
3
Description
Respiratory depression
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
PHysical examination
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group included women with epidural method, receiving bupivacaine 0.12% 125/0% or rupivacaine 0.1-0.2% + fentanyl 51 μg per 10-15 ml volume.
Category
Rehabilitation
2
Description
Control group: Natural childbirth
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان طالقانی تبریز
Full name of responsible person
دکترحجت پورفتحی
Street address
Taleghani hospital, Rah ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3442 4425
Email
pourfathih@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. abolghasem jouyban
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
3344280 0413
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
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
Dr. Hojjat Pourfathi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 914 313 8969
Email
pourfathih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hojjat Pourfathi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 914 313 8969
Email
pourfathih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hojjat Pourfathi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.32,University Ave., opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
3345697
Phone
+98 914 313 8969
Email
pourfathih@tbzmed.ac.ir
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