Protocol summary

Summary
This study aimed to determine the effect of skin contact on on exclusive breastfeeding Materials and Methods:In this RCT, 114 healthy primiparous mothers and their neonates were recruited in Om-ol-banin (pbuh) hospital in Mashhad. Upon hospital admission, mothers in active labor were allocated randomly to either SSC or routine care. In the intervention group, SSC was continuously performed during the first 2 hours of post-birth. In controls as is routine Om-ol-banin (pbuh) hospital, the first contact and breastfeeding were initiated after repairing the routine episiotomy and delivering neonatal routine care. Mothers in both groups were interviewed on the 28th days postpartum to determine the infants' feeding practice in neonatal period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091610848N1
Registration date: 2014-02-11, 1392/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Aghdas Karimi
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 85 91511
Email address
karimia901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2007-07-27, 1386/05/05
Expected recruitment end date
2007-11-11, 1386/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mother infant skin to skin contact on on exclusive breastfeeding
Public title
Mother infant skin to skin contact
Purpose
Supportive
Inclusion/Exclusion criteria
Eligibility criteria: age 18-35; Literacy at least in Persian language;single pregnancy; pregnancy desires;normal delivery; lack of spouse abuse; marital problems ; lack of adverse events; lack of risk behaviors in the mother or wife (of jail, addiction); the use of antidepressants; no history or current medical condition; infertility
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
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
mashhad university of medical science
Street address
mashhad - mashhad university of medical science
City
mashhad
Postal code
Approval date
2007-07-18, 1386/04/27
Ethics committee reference number
86154

Health conditions studied

1

Description of health condition studied
exclusive breastfeeding
ICD-10 code
Pregnancy,
ICD-10 code description
The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes)

Primary outcomes

1

Description
exclusive breastfeeding
Timepoint
one month after
Method of measurement
questioner

Secondary outcomes

1

Description
breastfeeding
Timepoint
one month after
Method of measurement
Questionnaire

2

Description
anxiety to infant
Timepoint
one month after
Method of measurement
questioner

Intervention groups

1

Description
In the intervention group, SSC was continuously performed during the first 2 hours of post-birth
Category
Other

2

Description
In controls as is routine Om-ol-banin (pbuh) hospital, the first contact and breastfeeding were initiated after repairing the routine episiotomy and delivering neonatal routine care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
om olbanin hospital mashhad
Full name of responsible person
Street address
City
mashhad

2

Recruitment center
Name of recruitment center
om olbanin hospital mashhad
Full name of responsible person
Street address
City
mahhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
mohsen tafaghodi
Street address
mashhad university of medical science
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical science
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
mohsen tafaghodi
Street address
mashhad university of medical science
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical science
Proportion provided by this source
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
Mashhad university of medical science
Full name of responsible person
Ahdas karimi
Position
Student
Other areas of specialty/work
Street address
Ebnesina, Mashhad university of medical science
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
karimia901@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical science
Full name of responsible person
Aghdas karimi
Position
Atudent
Other areas of specialty/work
Street address
Ebnesina, Mashhad university of medical science
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
karimia901@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Aghdas Karimi
Position
Student
Other areas of specialty/work
Street address
Ebnesina, Mashhad University of Medical Science
City
Mashhad
Postal code
Phone
00
Fax
Email
karimia901@mums.ac.ir
Web page address

Sharing plan

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