The effect of postpartum home visit on mothers' knowledge and attitude about exclusive breastfeeding, incidence of some complications of lactation and physiological jaundice in neonates in hospital
The effect of postpartum home visits on mothers' knowledge and attitude about exclusive breastfeeding, the incidence of some neonatal complications and physiological jaundice in infants.
Design
The study consisted of two intervention and control groups. The sample size was 100. The sampling method was simple and purposeful. The method of randomization and division of samples is based on permutation block design with 4 sizes.
Settings and conduct
The study will be performed on vaginal delivery women at Imam Khomeini Hospital in Falavarjan. The intervention group received 5 home visits. During the visits the training will be carried out as scheduled, the problems of mothers and infants will be followed up and appropriate action taken.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal vaginal delivery mothers who were hospitalized for less than 48 hours.
Exclusion criteria: Mothers with complications of pregnancy and childbirth or their neonates with pathological jaundice are excluded.
Intervention groups
Intervention group: after delivery receive 5 visits in home that education will be given to each patient according to the program and the patient will be followed for problems.
Control group: receive postpartum care through health centers.
Main outcome variables
knowledge and attitude about exclusive breastfeeding.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046055N1
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
razieh fallahnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5263 0719
Email address
atosa2007r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postpartum home visit on mothers' knowledge and attitude about exclusive breastfeeding, incidence of some complications of lactation and physiological jaundice in neonates in hospital
Public title
The effect of postpartum home visit on mothers' knowledge and attitude about exclusive breastfeeding, incidence of some breastfeeding complications
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Willingness to participate in the study 2- Uncomplicated normal delivery 3- Pregnancy age between 37 to 42 weeks 4- Infant weight between 2500 and 4000 g5- Hospital stay less than 48 hours6- Home distance to hospital less than 20 km 7-Iranian race Filling out the written form of consent to participate in the study.
Exclusion criteria:
1. Mothers with high-risk pregnancies such as: diabetes, hypertension, vaginal bleeding 2- neonatal premature 3- neonatal polycythemia 4- cephalohumatoma 5- It can be excluded for any reason that the mother does not wish to continue the project.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
286/5000 4-block
The sampling method is goal-based.
Randomization: According to the four-dimensional random permutation blocks method (using the letter A for the intervention group and the letter B for the control group and using 4-blocks 1-AABB 2-BBAA 3 – ABAB 4-BABA And thus randomized sampling to complete sampling).
The tool used to randomize software is Random Alocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of shiraz university of medical sciences
Street address
Central building of shiraz university of medical sciences،zand st. shiraz
City
shiraz
Province
Fars
Postal code
71345-1978
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
IR.SUMS.REC.1397.917
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean score of knowledge and attitude about exclusive breastfeeding.
Timepoint
Before study and day 42 postpartum
Method of measurement
Knowledge and Attitude Questionnaire(Iowa infant feeding attitude scale)
Secondary outcomes
1
Description
breast engorgment rate،nipple sore،mastitis
Timepoint
-Days 3,7,14 and 42 postpartum
Method of measurement
Questionnaire
2
Description
The incidence of physiological jaundice
Timepoint
days 3 and 7 postpartum
Method of measurement
Questionnaire and researcher-made checklist Questionnaire and researcher-made checklist
3
Description
Indicators of physical growth include height, weight and head circumference
Timepoint
Day 42 postpartum
Method of measurement
Tachometer, Tape Meter, Weight
4
Description
Exclusive breastfeeding rates
Timepoint
Day 42 postpartum
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Five visits on day 1 (before hospital discharge) 3 - 7 - 14 - 42 Postpartum receive
Category
Lifestyle
2
Description
Control group: phone calls are made to them on days 3-7 - 14 - 42, their status is checked and questionnaires are completed by telephone. question is asked.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Razieh Fallahnejad
Street address
Basij Street, Islamic Republic Square
City
Falavarjan
Province
Isfehan
Postal code
8451646731
Phone
+98 31 3742 1011
Fax
+98 31 3742 7043
Email
Emam-falavarjan-stat@mui.ac.ir
Web page address
https://www.falahos.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Zarshenas
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
mahnaz_zarshenas@yahoo.com
Web page address
https://nurs-midwif.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Razieh Fallahnejad
Position
Msc Student Of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
دانشگاه علوم پزشکی شیراز ، فلکه نمازی،دانشکده پرستاری مامایی
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
Atosa2007r@yahoo.com
Web page address
https://nurs-midwif.sums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Zarshenas
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Fatemeh Faculty of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
mahnaz_zarshenas@yahoo.com
Web page address
https://nurs-midwif.sums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Razieh Fallahnejad
Position
university student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Fatemeh Faculty of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
Atosa2007r@yahoo.com
Web page address
https://nurs-midwif.sums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
After defending the thesis from May 2020 onwards
To whom data/document is available
Researchers working in academic and scientific centers
Under which criteria data/document could be used
To do more and to improve
From where data/document is obtainable
Corresponding Author Dr. Mahnaz Zarshenas mahnaz_zarshenas@yahoo.com
What processes are involved for a request to access data/document
he responsible author is asked to be answered from week to month