To Assess the Effect of a Training Program about Maternal Fetal Attachment (MFA) Skills on Prenatal Attachment among Iranian First Time Pregnant Women
Design
A clinical trial with a control group, with parallel groups, one blind and randomized
Settings and conduct
From selected health care centers eligible pregnant women were selected purposively and was randomly divided into two groups; Intervention group: received a training program on two MFA skills. Face to face education about touching the fetus, counting and recording the daily fetal movement was provided by the researcher in the intervention group. Control group: received the routine antenatal care. Using Cranley's Maternal Fetal Attachment Scale (MFAS) the data were collected at baseline (28th weeks of pregnancy) and after intervention.The data analysor was blinded regarding to the division of the groups and type of intervention in every group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Iranian women; First time pregnancy; Being 18-35 years old; Having Literacy; Having no medical problem during pregnancy or a history of mental disorders; Normal pregnancy without use of assisted reproductive treatments; Singleton pregnancy; Gestational age between 20-22 weeks.
Non-inclusion Criteria:
Life threatening event during last 6 months; Pregnancy with assisted reproductive treatment; Multiple pregnancy; Substances abuse before and during pregnancy
Intervention groups
Intervention: In addition to prenatal care, Intervention group was taught to touch and count their fetal movement after consuming breakfast for 30 minutes in left lateral position for one month from 28 weeks of pregnancy.
Control: In the control group, the usual education about prenatal care and fetal movements were done.
Main outcome variables
Maternal Fetal Attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100516003936N4
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Kobra Salehi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 4243 2929
Email address
k_salehi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
2015-05-22, 1394/03/01
Actual recruitment end date
2015-07-16, 1394/04/25
Trial completion date
2015-09-23, 1394/07/01
Scientific title
The Effect of Education of Attachment Skills on Maternal Fetal Attachment of Pregnant Women
Public title
Effect of Education on Maternal Fetal Attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian women
First time pregnancy
Being 18-35 years old
Having Literacy
Having no medical problem during pregnancy or a history of Mental disorders
Normal pregnancy without use of assisted reproductive treatments
Singleton pregnancy
Gestational age between 20-22 weeks
Exclusion criteria:
Life threatening event during last 6 months
Pregnancy with assisted reproductive treatments
Multiple pregnancy
Drugs abusing before or during pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Actual sample size reached:
53
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible pregnant mothers randomly allocated into two groups of intervention and control using table of random numbers. Being odd or even for the
intervention group was selected through drawing.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study group was labled as A and B; So the data analysor was blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
293259
Health conditions studied
1
Description of health condition studied
Emotinal Relationship between Mother and Fetus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal Fetal Attachment
Timepoint
Before intervention and one month afetr begining the intervention
Method of measurement
Cranly Maternal Fetal Attachment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to prenatal care, intervention group was taught to touch and count their fetal movement after consuming breakfast for 30 minutes in left lateral position for 1 month from 28 weeks of pregnancy.
Category
Behavior
2
Description
Control group: In the control group, the usual education about prenatal care was done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirieh Health Care Center
Full name of responsible person
Kobra Salehi
Street address
4 th St, Amirieh Town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3775 7509
Fax
+98 31 3775 7509
Email
k_salehi@nm.mui.ac.ir
Web page address
http://isfhealth2.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/fa/
Grant name
293259
Grant code / Reference number
293259
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Kobra Salehi
Position
PHD Candidate of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kobra Salehi
Position
PHD Candidate of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8474166386
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kobra Salehi
Position
PHD Candidate of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8474166386
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
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
Some parts of the data, such as information about the main study outcome, will be shared.
When the data will become available and for how long
Access to the information will be started at 6 months after printing the results.
To whom data/document is available
Researchers working in academia and scientific instituations
Under which criteria data/document could be used
The data will be available for midwifery experts on the reasonable and acceptable reasons and analysis of the data will be possible with obtaining the written permission from the research team.
From where data/document is obtainable
Information will be shared by sending a request to the responsible person for the study.
k_salehi@nm.mui.ac.ir
What processes are involved for a request to access data/document
If the request contains the causes of the use of the data and the requesting person clearly introduces his/her professional identity and after confirmation of his/her identity, this information will be provided to him/her at the earliest opportunity. This documentation will be in Persian.