Objectives: To determine the effect of counseling on maternal-fetal attachment in women with unintended pregnancy.
Design: Two-armed randomized controlled trial.
Conduct: This study will be conducted on women with unintended pregnancy at the ages between 15-49 years old. The researcher will refer to the health centers of Ardabil and will provide a list of women with unintended pregnancy in 18-24 weeks of gestational age, then will call them and if they comply with the eligibility criteria and have tendency to participate in study, they will be invited to be present at the health center. Pre-test questionnaires will be completed and maternal-fetal attachment questionnaire will be analyzed and women with low and middle score will be included in the study. Then women will be randomly assigned into two groups (one group receiving counseling about attachment and one control group) through block randomization with block sizes of four and six.
Participants: 80 women with unintended pregnancy ages 15-49 years old.
Interventions: For intervention group, six group sessions once a week in six consecutive weeks and 1 to 3 sessions individual counseling about topics of Changes in pregnancy, fetal growth and development, nutrition, the importance of maternal-fetal attachment, fetal movement counting, the image of the fetus and etc. will be provided.
The main outcome variable is maternal-fetal attachment and secondary outcomes are depression and anxiety that will be assessed before and 4 weeks after the end of intervention by questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122710324N36
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology University Tabriz Medical Science
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of counseling on the maternal- fetal attachment among women
with unintended pregnancy: a randomized controlled trial
Public title
Effectiveness of counseling on the maternal- fetal attachment among women
with unintended pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy; gestational age over than 18 weeks; Having no obstetrics problems (threatened abortion, signs of preterm labor, Preeclampsia, bleeding); Unwanted or mistimed pregnancy.
Exclusion criteria: History of mental illness or having it currently; History of diabetes; high blood pressure, bleeding, premature delivery or affected by them currently; Using Psychiatric drugs or Psychoactive substances; History of marital disorders or problems according to the expression of women
Age
From 15 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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 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
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1104
Health conditions studied
1
Description of health condition studied
Unintended Pregnancy
ICD-10 code
Z64.0
ICD-10 code description
Problems related to unwanted pregnancy
Primary outcomes
1
Description
Maternal-fetal attachment
Timepoint
Before intervention and four weeks after the end of intervention
Method of measurement
Materna-fetal attachment questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention and four weeks after the end of intervention
Method of measurement
Edinburgh depression scale
2
Description
Anxiety
Timepoint
Before intervention and four weeks after the end of intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI)
Intervention groups
1
Description
The intervention group will receive six group sessions once a week in six consecutive weeks and 1 to 3 sessions individual counseling about topics of Changes in pregnancy, fetal growth and development, nutrition, the importance of maternal-fetal attachment, fetal movement counting, the image of the fetus and etc.
Category
Behavior
2
Description
The control group will receive standard prenatal cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Ardabil
Full name of responsible person
Fatemeh Ekrami
Street address
Health centers, Ardabil city, Ardabil province
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Ekrami
Position
MSc student in counseling in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
Email
fatemeh.ekrami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz Tabriz
City
Tabriz
Postal code
Phone
+98 41 3479 7712
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)