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Comparison between the effect of skin to skin contact mother and newborn and routine care on temperature and breastfeeding successfulness in full term newborns after cesarean delivery.

Protocol summary

Summary
The aim of this randomized clinical trial is to determine and compare the temperature of mothers and newborns after cesarean delivery in two groups of skin to skin contact and routine care. For this purpose, eighty eight pairs of non emergency cesarean delivery mothers and term newborns with Apgar score more than seven will be selected and placed randomly in two groups of skin to skin contact (Forty four pairs of mothers and newborns) and routine care (Forty four pairs of mothers and newborns). In the skin to skin contact group, after surgery and transferring the mother to the ward, skin to skin contact will be done for one hour between the mother and the newborn. In the routine care group, according to hospital usual method, the newborn will be handed to the mother. The newborns’ temperatures in both groups will be measured in the operating room immediately after birth, in nursery ward, when being handed to the mother and every half hour for one hour with infrared ray thermometer on the forehead. Also, the mothers’ temperatures will be measured before and after the surgery, when being returned to the ward and every half hour for one hour with the same kind of thermometer. During this time, the mothers will be trained on how to breastfeed their newborns. The data collection tool is a questionnaire which includes four parts: (Demographic data, temperature record form of mothers and newborns, infant breastfeeding assessment tool and mothers satisfaction with the skin to skin contact care).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110037697N1
Registration date: 2012-09-16, 1391/06/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Shourangiz Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1330 5313
Email address
shorangiz.beiranvand@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Lorestan University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of skin to skin contact mother and newborn and routine care on temperature and breastfeeding successfulness in full term newborns after cesarean delivery.
Public title
The effect of skin to skin contact mother and newborn on temperature and breastfeeding in newborns after cesarean delivery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for mothers: Age of 18-36 years old, singleton pregnancy, non - emergency cesarean delivery with spinal anesthesia and gestational age of 38-42 weeks. Inclusion criteria for newborns: Full term, Maximum age of newborns 4 hours after birth (One - day newborn), newborns' birth weight of more than 2500 gram and first and fifth minute Apgar score of more than seven. Exclusion criteria for mothers: Any medical problems in mothers after surgery Exclusion criteria for newborns: Any medical problems in newborns which can disrupt skin to skin contact and breastfeeding
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by using of random numbers table and closed envelopes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Department of Research and Technology, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
Postal code
381351698
Approval date
2012-05-12, 1391/02/23
Ethics committee reference number
66375/200

Health conditions studied

1

Description of health condition studied
Temperature of newborn
ICD-10 code
P80.8
ICD-10 code description
Other hypothermia of newborn

2

Description of health condition studied
Breastfeeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast

Primary outcomes

1

Description
Temperature of Newborns
Timepoint
Before and immediately after intervention and every half hour for one hour during intervention
Method of measurement
Infrared ray thermometer on the forehead, IN4 model

2

Description
Infants' breastfeeding status
Timepoint
During intervention for one hour
Method of measurement
Standard questionnaire of the Infant Breastfeeding Assessment Tool (IBAT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the mother’s cesarean delivery and her transfer to the ward, the naked newborn, in prone position, will be placed between the mother’s breasts for skin to skin contact with her. To avoid heat wastage, the newborn’s head will be covered with a hat and his / her back will be covered with a blanket. The mother's and newborn’s temperatures will be measured immediately after skin to skin contact and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12.
Category
Prevention

2

Description
Control group: After the mother’s cesarean delivery and her transfer to the ward, the dressed newborn will be placed in the bassinet or in the mother’s bed as a hospital usual method. The mother's and newborn’s temperatures will be measured when newborn handed to her mother and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital related to Lorestan University of Medical Sciences
Full name of responsible person
Shourangiz Beiranvand
Street address
Nursing Department, Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Kaedi
Street address
Vice Chancellor for Research, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
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 of Lorestan 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shourangiz Beiranvand
Position
Master of nursing, Faculty member of Lorestan University of Medical Sciences
Other areas of specialty/work
Street address
Nursing Department, Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
Email
shorangizbiranvand@yahoo.com; shorangiz.beiranvand@lums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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