The present study aimed to determine the effect maternal - fetal attachment training on success and duration breastfeeding in primiparous women.
Design
In this study, 120 primigravid women referring to Health Centers are selected. Participants are randomly divided into intervention and control groups.
Settings and conduct
This study consists of two stages of prepartum and eight weeks postpartum. In the first stage, in the intervention group, 4 sessions of maternal attachment training (30 - 45 min) held and the control group receives the routin pregnancy care.
Participants/Inclusion and exclusion criteria
Being Iranian; literacy; No known medical conditions and mental illness; Being nulliparous; wanted pregnancy; gestational age of 28-34 weeks.
Hospitalization of the infant or mother for medical condition; Parents' separation from baby; Postpartum Depression
Intervention groups
The intervention group takes part in four sesessions of maternal fetal attachment training and the control group receives the routin pregnancy care.
Main outcome variables
The maternal fetal attachment using maternal fetal attachment scale is measured in both intervention and control groups before intervention, immediately after intervention and two weeks after the intervention.
The success and duration of lactation in the 4th and 8th weeks after delivery are measured using a lactation pattern questionnaire.
General information
Reason for update
Acronym
MFA
IRCT registration information
IRCT registration number:IRCT20120122008801N22
Registration date:2018-03-05, 1396/12/14
Registration timing:prospective
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of maternal fetal attachment training on success and duration of breast – feeding of primiparous women
Public title
"The effect of maternal fetal attachment on lactation"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Age between 18 - 35 years old
literacy
No known medical conditions and mental illness
Primigravida women
Wanted pregnancy
Gestational age of 28-34 weeks
Exclusion criteria:
No history of infertility
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization of this study is simple randomand. there is an individual randomization unit.Tool of randomization is sealed envelope.
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 Shahid Beheshti University of Medical Sciences
Street address
ValiAsr Ave, Niayesh Cross Road, Niayesh Complex,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
579 .1395. IR.SBMU.PHNM
Health conditions studied
1
Description of health condition studied
Emotional relationship between mother and fetus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
duration of breastfeeding
Timepoint
Four weeks after childbirth, Eight weeks after childbirth
Method of measurement
patterns of breastfeeding questionnaire
2
Description
success breastfeeding
Timepoint
Four weeks after childbirth, Eight weeks after childbirth
Method of measurement
patterns of breastfeeding questionnaire
Secondary outcomes
1
Description
Maternal- fetal Attachment
Timepoint
Before intervention, After the intervention, Two weeks after the intervention
Method of measurement
Cranley’s questionnaire
2
Description
Lactation success
Timepoint
Four weeks after birthو Eight weeks after birth
Method of measurement
Lactation Pattern Questionnaire
3
Description
Lactation duration
Timepoint
Four weeks after birthو Eight weeks after birth
Method of measurement
Lactation Pattern Questionnaire
Intervention groups
1
Description
The intervention group take part in four 30minute sessions of maternal-fetal attachment training.
Category
Behavior
2
Description
The control group receives the routine pregnancy care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem hospital
Full name of responsible person
Arash poladi
Street address
Phase 3 و Ekbatan Settlement و Tehran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4463 4196
Fax
+98 21 4467 0885
Email
contact@saremcommunity.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences/ Tehran / Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Rahimi
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
NO.46, Fourth Street, Janat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1473935515
Phone
+98 21 4444 3901
Fax
Email
anahitarahimi7004@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali Asr Ave, Niayesh Cross Road,Niayesh Complex
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
Email
msimbar@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Rahimi
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
NO.46, Fourth Street, Janat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1473935515
Phone
+98 21 4444 3901
Fax
Email
anahitarahimi7004@sbmu.ac.ir
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
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