The effect of skin to skin contact between biological mother and the neonate born from surrogate mother immediately after birth on her attachment behaviors
Determine of the effect of skin to skin contact between biological mother and the neonate born from surrogate mother immediately after birth on her attachment behaviors.
Design
Clinical trial with 2 interference and control groups, single blind, nonrandomized on 50 mothers
Settings and conduct
Clinical trial semi experience, with post test and single blind. Infertility women who take surrogate mother in Tehran hospitals and infertility centers are goal of study.
Participants/Inclusion and exclusion criteria
Participants include: Infertility women who helped from surrogate mother and without any mental disorders that their infants were born in term full and do not need of special cares.
Intervention groups
The intervention group is biological mothers who have skin-to-skin contact with the baby after the birth of their surrogate uterus. After teaching skin-to-skin contact to biological mothers, after birth, the infant is placed in the surrogate womb immediately on the biological mother's bare breasts, and then for a quarter of the biological mother's behavior with the baby by two observers before discharge from the hospital. (Researcher and a colleague) is observed and recorded in the Avant questionnaire. In the control group, there is no skin contact between the biological mother and the baby, and before the baby is discharged, the mother's behavior with him is observed and recorded according to the mentioned method, and finally the scores obtained in each group are compared and analyzed.
Main outcome variables
Attachment score based on Avant questionnaire (emotional-proximity-caring behaviors)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051318N1
Registration date:2021-06-18, 1400/03/28
Registration timing:prospective
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Robabe Masoomi Disfani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7799 8927
Email address
tahere6758@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of skin to skin contact between biological mother and the neonate born from surrogate mother immediately after birth on her attachment behaviors
Public title
The effect of skin to skin contact on attachment behaviors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who have defects in their womb structure
One year must been passed after marriage and the effort for pregnancy
They should be mentally in a well shape for cooperation
Birth of infants in period of 37-42 weeks
APGAR score 9-10 in 5-10 minutes after the birth
Exclusion criteria:
Lack of permission and cooperation from the biological mother
Mothers, being with depression and mental problems
Birth of infants who have less than 37 weeks
Newborns with respiratory problems and need of special cares
Age
From 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering the fact that putting samples in 2 groups of control and interference can not occur accidently, samples were directed in their correct group only by post test and single blind.
Placebo
Not used
Assignment
Parallel
Other design features
This study is a quasi-experimental clinical trial study (considering that the allocation of samples to the control and intervention groups is not random) as a post-test only and a blind side (statistical analyst)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran university of Medical Sciences
Street address
East nosrat st, Doctor mirkhani st, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-02-05, 1399/11/17
Ethics committee reference number
IR.TUMS.FNM.REC.1399.197
Health conditions studied
1
Description of health condition studied
The effect of skin to skin contact between biological mother and the neonate born from surrogate mother immediately after birth on her attachment behaviors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Attachment score of biologic mother with newborn based on Avanet questionnaire
Timepoint
After delivering newborn to biologic mother and before discharge from hospital
Method of measurement
Avanet questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Biologic mothers who had contacted with their newborn after birth of surrogate mother. In order to achieve the objectives of the research, the form of collecting personal information and the scale of attachment of mother and infant after birth (Avant) are used. For the intervention group during a session on skin contact and its effects in accordance with the National Instruction of the Ministry of Health, the Deputy Minister of Treatment if available face to face in the first meeting and if not available by providing an educational CD prepared in accordance with The Ministry of Health's national guidelines will be taught before the baby is born, through a nurse or midwife appointed by the health center to assist the researcher.
Category
Behavior
2
Description
Control group: To collaborate in this study, mothers are selected using available sampling and then divided into two groups of skin contact and non-skin contact (control group). This division is not accidental because, in some infertility centers, after delivery from the surrogate mother, the baby comes into skin contact with the biological mother, while in some centers this is not the case. As a result, the researcher is not able to randomize individuals into two groups of intervention and control due to the internal protocols of these centers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran private hospitals that have Infertility and delivery section
Full name of responsible person
Robabe Masoomi Disfani
Street address
Bahman hospital, Iran zamin st, Qods town
City
Tehran
Province
Tehran
Postal code
1465795481
Phone
+98 21 8857 5901
Fax
+98 21 8857 9032
Email
info@gahmanhospital.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahrayian
Street address
Technology and investigation assistant, 6th floor, central organization of the university, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6670 6142
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran university of medical science
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
Tehran University of Medical Sciences
Full name of responsible person
Robabe Masoomi Disfani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nosrat St, Doctor Mirkhani St, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Robabe Masoomi Disfani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nosrat St, Doctor Mirkhani St, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Robabe Masoomi Disfani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nosrat St, Doctor Mirkhani St, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
Tahere6758@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
Except for given name and family name, all other datas of participants will be released.
When the data will become available and for how long
Starting of the period, after 6 months.
To whom data/document is available
The researchers in scholar and scientific departments.
Under which criteria data/document could be used
The researchers in scholar and scientific departments.
From where data/document is obtainable
Robabe Masoomi Disfani/Tahere6758@gmail.com
What processes are involved for a request to access data/document