The purpose of this is to examine the effect of self care education through telephone call regarding follow up procedure in pregnant women with risk factors for gestational diabetes. Inclusion criteria need at least two risk factors for gestational diabetes and exclusion criteria at least two non-response telephone call concerned with complications of pregnancy other than diabetes.This study is randomized clinical trial and studies the pregnant women who refer to health center of Abadan. Cases will be selected among 1000 pregnant women (8w) and having 2 risk factors for gestational diabetes. pregnant women, they will be divided in 2 groups randomly after demographic form ( i.e., age, age of pregnancy, level of education ect...). They will be the intervention group receive calls about diet, exercise, sings of diabetes every ten days during28 weeks of pregnancy. Control group will not do any intervention. We will test of Glucose Challenge Test and Body Mass Index on two groups at the end of 28 weeks of pregnancy. For women who have suspect Glucose Challenge Test over 130 miligeram on deciliter ) we will do Oral Glucose Tolerance Test. Finally, the evaluation of effect of intervention onset of gestational diabetes will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052115995N2
Registration date:2017-09-22, 1396/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Zahra Gorjian
Name of organization / entity
Abadan Medical Sciences College
Country
Iran (Islamic Republic of)
Phone
+98 63 1446 5494
Email address
gorjian-z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
All financial resources of this project are provided by Abadan School of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self care education through telephone Call on prevention of Gestational Diabetes among women who refer to Abadan's clinics 2017
Public title
Effect of Self Care Education through Telephone Call on the Prevention of Gestational Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18-35 years old during pregnancy; pregnancy age under 12 weeks; having two risk factors for getting gestational diabetes ( Body Mass Index over 30 kg/m2; History of diabetes in the first class family; History of diabetes in previous pregnancy; History of the birth a baby above 4 kilos); minimum fifth degree elementary education; no addiction and more important of other access to the landing phone or cell phone for calls and Exclusion criteria: disinclination for presence in the study; unresponsive to two calls at least and occurrence of complications related to expect diabetes pregnancy.
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:
1000
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
Abadan School of Medical Sciences
Street address
International Airport of Abadan,opposite of airport's Terminal
City
Abadan
Postal code
Approval date
2017-06-07, 1396/03/17
Ethics committee reference number
IR.ABADANUMS.REC1396.201
Health conditions studied
1
Description of health condition studied
O24
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Gestational Diabetes
Timepoint
before and after intervention
Method of measurement
GCT test and OGTT test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: After the necessary explanations about the method and objectives of the study, from the beginning of the study, using a fixed line or a combination of cell phone, every ten days until the 28th week of pregnancy, they will receive messages including diet, exercise exercises, diabetes symptoms, and so on.
Category
Prevention
2
Description
Control Group : No intervention was made on this group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics
Full name of responsible person
Zahra Gorjian
Street address
City
Abadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan School of Medical Sciences
Full name of responsible person
Mrs. Hajari
Street address
International airport of Abadan - Deputy of Education,Research and student
City
Abadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan School 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
Abadan School of Medical Sciences, Abadan, Iran
Full name of responsible person
Zahra Gorjian
Position
Faculty Member
Other areas of specialty/work
Street address
International airport, Deputy of education, Research and student
City
Abadan
Postal code
Phone
00
Fax
Email
gorjianzah@gmail.comgorjian-z@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan School of Medical Sciences, Abadan, Iran
Full name of responsible person
Zahra Gorjian
Position
Faculty member, MSc
Other areas of specialty/work
Street address
International airport, Deputy of Education, Research and student
City
Abadan
Postal code
Phone
00
Fax
Email
gorjianzah@gmail.comgorjian-z@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Abadan School of Medical Sciences, Abadan, Iran
Full name of responsible person
Zahra Gorjian
Position
Faculty Member
Other areas of specialty/work
Street address
International airport of Abadan, Deputy of Education, Research and student
City
Abadan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)