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Effect of prechildbirth counselling on breastfeeding practice of mothers with previous breastfeeding failure

Protocol summary

Study aim
Determining the effect of prenatal consultation on mothers breastfeeding functioning with previous failed breastfeeding attempts at Tabriz Health Care Center
Design
Controlled randomized clinical trial in two groups (intervention and control groups)
Settings and conduct
Before the onset of intervention, the form of informed consent, and then a demographic questionnaire, self-efficacy of breastfeeding and self-checklists of breastfeeding effecacy will be completed by the Participants. In the intervention group during pregnancy, group breastfeeding consultation will begin for four sessions. Furthermore, mothers in the intervention group will receive consultations until the 15th day after delivery, and also until the end of the 4th month, in case of any problems consultation will be done by telephone or their attendence in case of necessity. The control group will receive only a routine training in health care centers. mothers in both intervention and control groups will receive self-efficacy questionnaires on the 15th day, 2nd and 4th months after delivery about breastfeeding performance checklist includes infant weight gain checklist, frequency of exclusive breastfeeding and abundance of breastfeeding problems, to complete. Then they will be compared in two groups. The place of the study is Tabriz Health Centers
Participants/Inclusion and exclusion criteria
Participants in this study are 108 mothers , selected by random method. The random allocation of individuals to intervention and control groups is performed using four and six blocks (54 in each). Inclusion conditions: her last breastfeeding failed; have a singleton pregnancy;be in her third trimester of pregnancy. Conditions of failure to entry: recognized abnormalities in the fetus;High risk pregnancy;contraindications for lactation
Intervention groups
Counselling group:lactation counseling in the intervention group (54 persons) during group counseling sessions, in groups of 7 to 5, each session will start for 60-90 minutes and 4 sessions with a weekly intervals. Control group: This group will receive only routine health care during pregnancy.on the 15th ,2nd and 4th month after delivery,breastfeeding self-efficacy questionnaire and breastfeeding practice checklist including a checklist for neonatal weighing,the frequency of exclusive breastfeeding and the frequency of breastfeeding problems will be completed and then in two groups will be compared.
Main outcome variables
1) comparison Neonatal weigh rate at birth, 15 days, 2 and 4 months after delivery in two groups of intervention and control group 2 )Comparison of the frequency of exclusive breastfeeding on day 15, 2 and 4 months after delivery in two groups of intervention and control group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100109003027N19
Registration date: 2018-01-10, 1396/10/20
Registration timing: registered_while_recruiting

Last update: 2018-01-10, 1396/10/20
Update count: 0
Registration date
2018-01-10, 1396/10/20
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prechildbirth counselling on breastfeeding practice of mothers with previous breastfeeding failure
Public title
Effect of prechildbirth counselling on breastfeeding practice of mothers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having reading and writing literacy resident of Tabriz her last breastfeeding failed (failure in this study is meant for mothers who have passed a term pregnancy and have given birth to a healthy baby, yet for some reasons have used infant formulas alone or in combination with breastfeeding in order to feed their infants during the first 6 months of birth) have a singleton pregnancy able to attend continuously in counseling sessions be in her third trimester of pregnancy
Exclusion criteria:
recognized abnormalities in the fetus including congenital anomalies of the heart, brain, kidneys, visual problems, gastrointestinal upsets, cleft lip and cleft palate, oral and maxillofacial abnormalities, etc High risk pregnancy including preeclampsia, diabetes preterm labor, premature rupture of embryonic veins, thromboembolism, heart disease and third trimester bleeding contraindications for lactation (women with galactosomal infants; women taking certain drugs; women undergoing breast cancer treatment, women with HIV infection, women with active herpes simplex virus infection, women with Untreated tuberculosis, women who abuse drugs and, have no control over their alcohol consumption, and mental disorders which cause the mothers can not regularly feed their infants).
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
The number of pregnant women who were eligible to enter the study was selected by random blocking (stratification based on the type of delivery) using the WWW.RANDOM.ORG site with blocks 4 and 6 with a ratio of 1: 1 to two groups (receiving Counseling and control) will be allocated. The type of assignment is written on paper, written in matched envelopes, and will be numbered(Allocation Concealment).Assignment Sequences will be conducted by the person not involved in the research. The projects will be opened in the order of the participants in the study, and the type of intervention received will be determined by each contributor
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
515463945
Approval date
2017-10-11, 1396/07/19
Ethics committee reference number
IR.TBZMED.REC.1396.595

Health conditions studied

1

Description of health condition studied
Prevention
ICD-10 code
O92
ICD-10 code description
Other disorders of breast and lactation associated with childbirth

Primary outcomes

1

Description
Neonatal weigh rate
Timepoint
15 days, 2 and 4 months after childbirth
Method of measurement
Checklist designed by the research team related to neonatal weighing

2

Description
Determine the frequency of exclusive breastfeeding
Timepoint
15 days, 2 and 4 months after childbirth
Method of measurement
Exclusive Breastfeeding Checklist

3

Description
Determine the self-efficacy of mothers with failure of previous breastfeeding
Timepoint
15days,2 and 4 months after childbirth
Method of measurement
BSES questionnaire

4

Description
Determine the frequency of Breastfeeding Problems
Timepoint
15days,2 and 4 months after childbirth
Method of measurement
Checklist the frequency of breastfeeding problems

Secondary outcomes

empty

Intervention groups

1

Description
actation counseling in the intervention group (54 persons) during group counseling sessions, in groups of 7 to 5, each session will start for 60-90 minutes and 4 sessions with a weekly intervals.
Category
Prevention

2

Description
Control group: This group will receive only routine health care during pregnancy.on the 15th ,2nd and 4th month after delivery,breastfeeding self-efficacy questionnaire and breastfeeding practice checklist including a checklist for neonatal weighing,the frequency of exclusive breastfeeding and the frequency of breastfeeding problems will be completed and then in two groups will be compared.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz health centers
Full name of responsible person
shiva havizari
Street address
Tabriz health centers
City
Tabriz
Province
East Azarbaijan
Postal code
5154639354
Phone
+98 41 3657 7409
Email
Shiva.havizary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5154639354
Email
Shiva.havizary@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of 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 Science
Full name of responsible person
shiva havizari
Position
MSc student of conseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5154639354
Phone
+98 41 3479 6770
Fax
Email
Shiva.havizary@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences(nursing & midwifery faculty)
Full name of responsible person
fahimeh sehhatie shafaie
Position
Master of Midwifery/Assistant Professor
Latest degree
Master
Other areas of specialty/work
Street address
Tabriz,South Shariati,nursing & midwifery faculty)
City
Tabriz
Province
East Azarbaijan
Postal code
51745-347
Phone
+98 41 3479 6770
Fax
Email
Fahimehsehhatie@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical sciences(nursing & midwifery faculty)
Full name of responsible person
fahimeh sehhatie shafaie
Position
Assistant Professor of Midwifery, Faculty of Nursing and Midwifery, Tabriz
Latest degree
Master
Other areas of specialty/work
Street address
Tabriz,South Shariati,nursing & midwifery faculty)
City
Tabriz
Province
East Azarbaijan
Postal code
51745-347
Phone
00
Fax
Email
Sehhatief@tbzmed.ac.ir
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
نمونه گیری قبل از سال 1397 شروع شده است
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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