Protocol summary

Study aim
Determine the effect of two methods of Breastfeeding Education with and without the presence of Grandmothers on Breast feeding self-efficacy and infant feeding pattern in Nulliparous women
Design
Semi experimental study with control group, continuous sampling, with two parallel groups design of 70 patients.
Settings and conduct
This study will be conducted in the Breastfeeding Education class of Amiralmomenin Hospital. The content of educational materials in pregnancy in accordance with the standard country guidelines and twice in pregnancy in divided sections will be presented by Speech method. Pamphlet with colored images containing Breastfeeding material will be given to participants in Breastfeeding Education classes. Misconceptions about mother's milk and facts will be presented to maternal grandmothers with colored pamphlets. After delivery, Summary of Breastfeeding Educations presented in Pregnancy will be repeated, the film of healthy baby will be shown routine in the country and will be given help to the mother in breastfeeding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nullipara, low risk pregnancy, Singleton pregnancy, healthy fetus, 31week of gestational age and the absence of psychological disorders in Grandmother. exclusion criteria: Absent in breast feeding education class more than one session, The maternal grandmother is not caregiver of the mother after childbirth.
Intervention groups
In the intervention group, Nulliparous women Along with her mothers will attend in Breastfeeding Education classes , but in the control group, Nulliparous women will attend the classes alone.
Main outcome variables
Breastfeeding self-efficacy and infant feeding pattern.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N1
Registration date: 2018-06-12, 1397/03/22
Registration timing: prospective

Last update: 2018-06-12, 1397/03/22
Update count: 0
Registration date
2018-06-12, 1397/03/22
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Two Methods of Breastfeeding Education with and without Grandmothers Attendence on Breastfeeding Self-Efficacy and Infant Feeding Pattern in Nulliparous Women
Public title
Effect of Grandmothers Breastfeeding Education on Breastfeeding in Nulliparous Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality understand and speak to Persian nullipara Singleton pregnancy low risk pregnancy 18-35 years old 31-34 week of gestational age healthy fetus without congenital malformation lack of contraindication of lactation the absence of psychological disorders in the neonate maternal grandmother delivery in Amiralmomenin Hospital.
Exclusion criteria:
Absent in breast feeding education class more than one session The maternal grandmother is not caregiver of the mother after childbirth.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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 Iran University of Medical
Street address
Hemmat Highway - next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.IUMS.FMD.REC. 1396.9511373007

Health conditions studied

1

Description of health condition studied
Breast feeding Education in pregnant women with the attendence of grandmothers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The difference in Breast feeding self-efficacy with 13-item Breast feeding self-efficacy tool in two groups: control and intervention
Timepoint
Determine the Breast feeding self-efficacy score at the time of discharge from the hospital, 4 weeks later and 8 weeks after delivery
Method of measurement
13-item Breast feeding self-efficacy tool

2

Description
Differences in the frequency of infant feeding patterns in two groups of control and intervention
Timepoint
Frequency of infant feeding patterns at 4 and 8 weeks postpartum
Method of measurement
Mother-phone questioning about infant feeding patterns

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Participation of Nulliparous Women in Breastfeeding Education classes without Attendence of Grandmothers
Category
Other

2

Description
Intervention group: Participation of Nulliparous Women in Breastfeeding Education classes with Attendence of Grandmothers
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Gharaei Tayebeh
Street address
Nazi Abad, Shahid Shir Mohammadi Street, opposite Sardar Forest Park
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6210
Fax
+98 21 5534 6301
Email
tayebeh.gharaei@gmail.com
Web page address
https://mail.google.com/mail/u/0/#inbox/1631af5558c7e9b0?compose=163ac5efd6482d74

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Shahid Hemmat highway, District 2
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9024
Fax
+98 21 8805 2248
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Tayebeh Gharaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1744943683
Phone
+98 21 7740 6278
Email
tayebeh.gharaei@gmail.com
Web page address
https://mail.google.com/mail/u/0/#inbox/1631af5558c7e9b0?compose=163ac5efd6482d74

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gharaei Tayebeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1744943683
Phone
+98 21 7740 6278
Email
tayebeh.gharaei@gmail.com
Web page address
https://mail.google.com/mail/u/0/#inbox/1631af5558c7e9b0?compose=163ac5efd6482d74

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
l.amirifarahani@gmail.com
Web page address

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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