(1) Objectives:
Comparison effect Crawl and Routine breastfeeding on breastfeeding behaviors in two hours after childbirth.
Comparison effect Crawl and Routine breastfeeding on continuous exclusive breastfeeding.
(2)Design:
60 newborn of primi or two gravida women referred to Ali-Ebn-Abitaleb hospitals' Zahedan during 2009 to 2011 years.
(3) Setting and Conduct:
Participants will be randomized by judgmental sampling, then will be divided to two methods (Crawl and Routine breastfeeding) by simple random allocation.
(4) Participants including major eligibility criteria:
Inclusion criteria: 60 women with term and singleton pregnancy, without episiotomy in temperature of birth room 23 to 25 centigrade.
Exclusion criteria: previous medical disorder and smoking , use pethidine / promethazine during labor, acute complication (prolong labor, postpartum hemorrhage, meconium and distress respiration newborn.
(5) Intervention:
Crawl group will be inserted between breasts and abdomen of the mother;s skin immediately after birth (before any interventions) for 60 minutes until start breast Crawl without helping, and Routine group only lie between breasts and abdomen of mother's skin for 15 minutes, thus newborn wrap and close mother position and caregiver help for breastfeeding during 1 hour. During this time evaluate 6 items of expository early movement and 4 items successful breastfeeding behavior with Infant Breastfeeding Assessment Tool (IBFAT) scale and skin sense satisfaction with newborn contact with numeric scale (0-5). Also, continuous exclusive breastfeeding will be assessed during 6 month.
(6)Variables main outcome measure:
early six breastfeeding movement and four successful breastfeeding behavior, and skin sense satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305205169N2
Registration date:2013-12-27, 1392/10/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-27, 1392/10/06
Registrant information
Name
Shahin-Dokht Navvabi-Rigi
Name of organization / entity
Pregnancy Health Research Center, Zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1259
Email address
navabi-rigi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Zahedan University Of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of Two Crawl and Routine Breastfeeding Methods on Breastfeeding Outcomes Early After Birth
Public title
Effect of Crawl method on breastfeeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: primi /two gravida with term and singleton pregnancy and do not episiotomy,Body Mass Index ( BMI )<29.
Exclusion criteria: previous medical disorder and smoking , used pethidine / promethazine during labor, acute complication (prolong labor, postpartum hemorrhage, meconium and distress respiration newborn.
Age
To 6 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
type of randomization is simple.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zahedan University Of Medical Sciences
Street address
Dr Hesabi Sq. Pardis Of Zahedan University Of Medical Sciences
City
Zahedan
Postal code
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
883192
Health conditions studied
1
Description of health condition studied
Promoting breastfeeding
ICD-10 code
Z39.0
ICD-10 code description
Care and examination immediately after delivery
Primary outcomes
1
Description
Successful breastfeeding behaviour
Timepoint
during 2 hour after birth
Method of measurement
Infant Breastfeeding Assessment Tool (IBFAT)
Secondary outcomes
1
Description
Exclusive breastfeeding
Timepoint
4th after intervention and 6th after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Crawl group: Immediately after birth, in first step skin newborn will dry (except hands), next face to face and smell will contact near mother during 1 minute, end step immediately skin to skin will contact between abdomen and breasts during 1 hour and will wait for observation Crawl forward nipple.
Category
Behavior
2
Description
Control group (Routine group): Immediately after birth, newborn dry, next will contact skin mother's during 15 minute, and will wrap towel and lied near mother nipple and end step will observe during 1 hour.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn-Abitaleb hospital
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University Of Medical Sciences
Full name of responsible person
Sodabeh Hashemzehi
Street address
Dr Hesabi sq.Pardis Zahedan University Of Medical Sciences
City
Zahedan
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, Zahedan 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
Pregnancy Health Research Center, Zahedan University Of Medical Sciences
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
Faculty of mastery
Other areas of specialty/work
Street address
Mail box 1379, Mashahir sq. Nursing and Midwifery Zahedan School
City
Zahedan
Postal code
Phone
+98 54 1244 2482
Fax
Email
shahinnavabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pregnancy Health Research Center, Zahedan University Of Medical Sciences
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
faculty mastery of midwifery
Other areas of specialty/work
Street address
Mail box1379, Mashahir Sq. Zahedan Nursing and Midwifery School
City
Zahedan
Postal code
Phone
+98 54 1244 2482
Fax
Email
shahinnavabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pregnancy Health Research Center, Zahedan University Of Medical Sciences
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
mastery of Midwifery
Other areas of specialty/work
Street address
Mail box1379, Mashahir Sq. Nursing and Midwifery School
City
Zahedan
Postal code
Phone
+98 54 1244 2482
Fax
+98 54 1244 2481
Email
shahinnavabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)