Protocol summary

Summary
The overall basic objective of this study are, to determine the effect of the correct way of breastfeeding on the amount of glucose in 6 hours after the birth ,to determine the blood sugar of the neonates,to compare the hypoglycemia in two group,to show relationship between the blood sugar of neonates and their demographic features. Thisis an interventional study including participation 70 people. Inclusion criteria included : totally healthy pregnant women in the final trimester of pregnancy with the live delivery ; full term healthy neonate with intrauterine age ( 37 weeks to 41 weeks and 6 days ) 2500 - 3900 g weighing born in hospital . Exclusion criteria included :the lake of tendency of the client to take prat in the reaserch,neonate ; healthy full-term neonate at the moment of the birth ,but during the study ( first 6 hours after from birth) are unhealthy for any reason ;the womon who dont take any medication but in the first 6 hours after birth have to take medicine (expect complementries)for any reason.in this study .reasercher trains mothers about the correct way of breastfeeding and its relationonship and reduction of blood sugar andadventages of this system. Reasercher also determines and compares blood sugar of neonates in 3 steps and show the impact of training on 2 group

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013090414561N1
Registration date: 2013-10-16, 1392/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-16, 1392/07/24
Registrant information
Name
fatemeh Allahkarampour
Name of organization / entity
Shiraz University Of Medical Scince
Country
Iran (Islamic Republic of)
Phone
+98 74 2333 1414
Email address
akramipour_f@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-09-11, 1392/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the breastfeeding training to mothers on the full term neonates blood glucose
Public title
The effect of the breastfeeding training to mothers on the full term neonates blood glucose in the Shahid rajaee Hospital ,Gachsaran,1392
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: healthy mothers with no deseas such as (hypertension, lupus, heart disease, diabetes, etc.) during pregnancy; mothers who are in the last trimester of pregnancy (37 weeks gestation) with ability of reading and writing (at least in grade of 5 of primary school)with no education in nursing and midwifery; mother consen to take part in this study; mothers who have live delivery in the hospital in Gachsaran; Primigravida;Healthy Neonate with the 37-41 weeks of intrauterine age weighing 2500-3900 g who born in Rajai hospital; mothers with no medication in pregnancy except supplements. Exclusion criteria: mothers with no tendency to participate in this study;mothers who are not able to participate in entire sessions of training,neonates who are healthy at the moment of the birth but get some sorts of problem for any reason during the study (6 hours after birth);mothers who have no medication but supplement during the pregnancy but eithin the 6 hours have to take medication.
Age
From 37 years old to 41 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Shiraz University of Medical Science
Street address
Setad
City
Shiraz
Postal code
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
ct-92-6613

Health conditions studied

1

Description of health condition studied
Neonate blood glocose range
ICD-10 code
p70.4
ICD-10 code description
Other Neonatal hypoglycaemia

Primary outcomes

1

Description
Blood glocouse range
Timepoint
The first time - the third and sixth hours postnatal
Method of measurement
Capillary

Secondary outcomes

empty

Intervention groups

1

Description
teach correct breastfeeding way to mothers during pregnancy
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Rajai Gachsaran Hospital
Full name of responsible person
Fatemeh allahkarampour
Street address
No 675, Bahonar6
City
Gachsaran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research -Shiraz University of Medical Science
Full name of responsible person
Fatemeh Hashemi
Street address
Shiraz University Of Medical Science
City
Shiraz
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 -Shiraz University of Medical Science
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
Shiraz Medical Scince University
Full name of responsible person
Fatemeh Allahkarampour
Position
Student
Other areas of specialty/work
Street address
Bahonar 6.675
City
Gachsaran
Postal code
7581895499
Phone
+98 74 2333 1414
Fax
+98 74 2222 0575
Email
fallahkarampour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fatemeh Hashemi
Position
MA
Other areas of specialty/work
Street address
koye Daneshgah
City
Shiraz
Postal code
Phone
+98 71 1646 6560
Fax
Email
akramipour_f @sums.ac.ir akramipour.nurse@gmail.coallahkarampour@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Fatemeh Allahkarampour
Position
MA student
Other areas of specialty/work
Street address
Bahonar 6.No 675
City
Gachsaran
Postal code
Phone
+98 74 2222 0575
Fax
Email
fallahkarampour@gmail.com
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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