Protocol summary
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Study aim
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The effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
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Design
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This study is a randomized clinical trial that will be conducted on 80 pregnant women with unplanned pregnancy. Forty pregnant women randomly ( block randomization) will be allocated to each group. Blindness does not take place.
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Settings and conduct
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Sampling will be done in a two-stage stratified process from comprehensive health centers. From each class, four centers will be selected by cluster sampling, and randomly 2 centers will be considered for intervention groups and 2 centers for control group. The names of the centers will be written in a separate sheets and then place inside the bag. The first two centers will be for intervention groups and the next two centers for control group. The main researcher will be in the centers allocated for intervention group in odd days and in the centers allocated for control group in even days and will randomly select 10 participants.
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Participants/Inclusion and exclusion criteria
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Include criteria: age between 18 to 35; unplanned pregnancy; education level at guidance; single pregnancy; no drug abuser; gestational age between 28 to 34 weeks; and living with husband.
No include criteria: having underlying medical conditions and obstetrical complications such as: bleeding; diabetes; hypertension; preterm labor.
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Intervention groups
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Intervention group will receive four 60 minutes sessions group counseling weekly during third trimester of pregnancy. Control group will just receive routine care. The questionnaires will be fulfilled by mothers two weeks after counseling sessions, and a short counseling session will be held at same day.
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Main outcome variables
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Maternal fetal attachment
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161230031662N5
Registration date:
2018-07-17, 1397/04/26
Registration timing:
prospective
Last update:
2019-04-09, 1398/01/20
Update count:
1
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Registration date
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2018-07-17, 1397/04/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-07-18, 1397/04/27
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Expected recruitment end date
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2018-09-22, 1397/06/31
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Actual recruitment start date
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2018-07-21, 1397/04/30
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Actual recruitment end date
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2018-09-11, 1397/06/20
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Trial completion date
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2018-09-11, 1397/06/20
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Scientific title
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Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
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Public title
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Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 18 to 35 years old
Premature birth and unwanted pregnancy
Having at least guidance literacy
Single pregnancy
Not having abuse and drug addiction
Gestational age between 28 and 34 weeks
Living with spouse
Exclusion criteria:
Having underlying medical illnesses
Complications such as bleeding, diabetes, hypertension and early delivery
Severe psychological problems
Absence of mother to receive 2 consecutive consultations
Unwillingness to continue attending meetings
Twin
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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80 samples will include in study; 40 women in intervention and 40 in control group
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-19, 1397/02/29
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Ethics committee reference number
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IR.ABZUMS.REC.1397.017
Health conditions studied
1
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Description of health condition studied
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maternal fetal attachment
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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maternal fetal attachment
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Timepoint
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before intervention, 2 weeks after intervention
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Method of measurement
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cranley questinnaire
Intervention groups
1
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Description
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The intervention group participates in 4 group counseling sessions on maternal and fetal attachment that runs once a week and in groups of 10 people. Duration of each session is about 1 hours.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Karaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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he total potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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scientific studies
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From where data/document is obtainable
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send an email to Dr. Razieh Lotfi.
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What processes are involved for a request to access data/document
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Up to a week after sending the email address
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Comments
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