main goal:Identifying the effects of postpartum education on newborn breastfeeding behavior at discharge
specific objectives:
1- identifying newborn breastfeeding behavior before positioning/latch on education in intervention and control group
2- comparing newborn breastfeeding behavior before positioning/latch on education between intervention and control group
3-identifying newborn breastfeeding behavior after positioning/latch on education in intervention and control group
4-comparing newborn breastfeeding behavior after face to face education of positioning/latch on, between intervention and control group
Design
after completing the initial questionnaire,mothers will be randomly divided into intervention or control groups using simple random allocation method . for choosing that the first one is in control or intervention , we will draw a coin(tap or line) .participants will be allocated one in between till completion of sample size
Settings and conduct
postpartum and cesarean wards of al-zahra education and treatment center of Rasht city
Participants/Inclusion and exclusion criteria
inclusion criteria: women with singleton pregnancy and vaginal or cesarean delivery
exclusion criteria:
pregnancies with medical or surgical complications,history of prolonged or complicated deliveries,anatomical abnormalities or breast surgeries which prevent breastfeeding, newborn APGAR score below 7, newborn admission in NICU, cleft lip or palate or other abnormalities that act as barrier for newborn feeding
Intervention groups
women with singleton pregnancies and vaginal or cesarean delivery who have inclusion criteria of study
Main outcome variables
newborn feeding behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190111042321N1
Registration date:2019-02-16, 1397/11/27
Registration timing:registered_while_recruiting
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Zahra Gholipour Soleymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 7106
Email address
elahe.gholipour20@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of postpartum education to mother about breastfeeding position /latch on newborn feeding behavior at discharge
Public title
effect of postpartum education to mother about breastfeeding position /latch on newborn feeding behavior at discharge
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
woman with singleton term pregnancy who had vaginal birth or cesarean birth
Exclusion criteria:
pregnancies with medical complications
prolonged obstructed labors
anatomical defects in breast which an obstacle for breastfeeding
APGAR score below 7
newborn admission in NICU
cleft lip/palate or other anomalies cause disorder in newborn feeding
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
2
pregnancies with medical complications.prolonged obstructed labors.anatomical defects in breast which an obstacle for breastfeeding.APGAR score below 7.newborn admission in NICU.cleft lip/palate or other anomalies cause disorder in newborn feeding.
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the initial questionnaire , mothers are randomly devided in to two intervention method for choosing than the first client is belonged to intervention or control group , we will draw a coin (tap or line).then for choosing the first one sampling will continue and participants will be allocated one in
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Azad university
Street address
pooltaleshan street,rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1396,165
Health conditions studied
1
Description of health condition studied
newborn breastfeeding behavior
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
newborn breastfeeding behavior
Timepoint
at beginning of study and at discharge
Method of measurement
with IBFAT instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals who have been admitted to the study who received face-to-face education about lactation and then had their baby's milking behavior checked. Control group:
Category
Behavior
2
Description
Control group: Individuals who have been admitted to the study who did not receive face-to-face training and their baby's milking behavior were checked during discharge.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital of Rasht
Full name of responsible person
Zahra Gholipour Soleimani
Street address
Namgo street,alzahra hospital
City
Rasht
Province
Guilan
Postal code
2345987554
Phone
+98 13 3229 5247
Fax
Email
azzahra@gums.ac.ir
Web page address
http://www.gums.ac.ir/azzahra
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Mirfallah
Street address
pooltaleshan street,Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
elahe.gholipour20@hotmail.com
Web page address
http://www.iaurasht.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zahra Gholipour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Islamic Azad University of Rasht,Lakan blv.,Rasht
City
Rasht
Province
Guilan
Postal code
2356984147
Phone
+98 013337106
Email
elahe.gholipour20@hotmail.com
Web page address
http://www.iaurasht.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Masjodi
Position
trainer
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Lakan blv.,Rasht
City
Rasht
Province
Guilan
Postal code
4147092163
Phone
+98 33337106
Email
ma_masjodi@yahoo.com
Web page address
http://www.iaurasht.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Gholipour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Lakani street
City
Rasht
Province
Guilan
Postal code
657893583
Phone
+98 13 3333 7106
Email
elahe.gholipour20@hotmail.com
Web page address
http://www.iaurasht.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