It is an experimental study. Objective: To compare the effectiveness of two teaching methods on pregnancy outcomes in discharge of patients with gestational diabetes. Inclusion criteria: 1.Gestational age of 28-36 weeks. 2. Hospitalized due to high blood sugar or gestational diabetes. 3. Failure to attend training classes on diabetes before study entry. 4. Literacy in reading and writing. Exclusion criteria: absence in one of the training sessions. Study: Pregnant women hospitalized due to high blood sugar or diagnosis of gestational diabetes in selected hospitals of Tehran University of Medical Sciences in year 2013. Sample size: A total of 126 people in the availability of hospital admission among women who want to be elected by the inclusion criteria are selected and divided into three groups of 42 subjects (two intervention groups and 1 control group). Intervention: The initial questionnaire will be completed by the researcher for the three groups. The control group will receive routine hospital care. In intervention group 1 in 2 sessions that every session takes 40 minutes in the form of individual or in groups, face to face training will be given in the case of gestational diabetes that the 30 minutes of lecture and 10 minutes will be allotted for questions and answers. In intervention group 2 will distribute the booklet to study their patients. Immediately to 1 month after delivery, the call will be taken by the researcher with patients and record sheet (pregnancy outcomes associated with maternal and fetal pregnancy outcomes) will be completed. Stillbirth cases will be reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031812840N1
Registration date:2013-04-12, 1392/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-12, 1392/01/23
Registrant information
Name
Masoomeh Senobari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4471 1953
Email address
m-senobari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-06, 1392/01/17
Expected recruitment end date
2013-09-22, 1392/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of two teaching methods on pregnancy outcomes in discharge of patients with gestational diabetes
Public title
The effect of training on outcomes of gestational diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1.Gestational age of 28-36 weeks.
2.Hospitalized due to high blood sugar or gestational diabetes.
3. Failure to attend training classes on diabetes before study entry.
4. Literacy in reading and writing.
5. Lack of having any known physical or mental condition that makes training impossible.
Exclusion criteria:
1.absence in one of the training sessions.
2. Lack of desire to continue working with research.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tohid square
City
Tehran
Postal code
1419733171
Approval date
2013-02-13, 1391/11/25
Ethics committee reference number
2967/130/د/91
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
024.4
ICD-10 code description
Diabetes mellitus arrising in pregnanncy
Primary outcomes
1
Description
Maternal and fetal outcome of gestational diabetes
Timepoint
Immediately to 1 month postpartum
Method of measurement
Self-made recording sheet
Secondary outcomes
1
Description
Reduce costs and improve infant after delivery
Timepoint
Immediately to 1 month postpartum
Method of measurement
Self-made recording sheet
Intervention groups
1
Description
Intervention 1: first initial questionnaire is completed by the researcher. In intervention group 1 in 2 sessions that every session takes 40 minutes in the form of individual or in groups,face to face training will be given in the case of gestational diabetes that the 30 minutes of lecture and 10 minutes will be allotted for questions and answers.Subjects that will be taught in the first sessions include: definition of gestational diabetes, its causes, symptoms, those at risk, control and treatment of gestational diabetes include training on glycemic control, and subjects that will be taught in the second sessions include: Nutrition, physical activity and exercise, insulin, pregnancy follow-up.Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.
Category
Behavior
2
Description
Intervention 2: first initial questionnaire is completed by the researcher. In intervention group 2, the booklet contains all the study material provided to the intervention group 1 will be distributed by the patient. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.
Category
Behavior
3
Description
Control group: first initial questionnaire is completed by the researcher. Patients in the control group would receive routine care hospital. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid akbar abadi hospital
Full name of responsible person
Street address
Molavi Square
City
Tehran
2
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Street address
Tehranpars
City
Tehran
3
Recruitment center
Name of recruitment center
Jame Zanan hospital
Full name of responsible person
Street address
7th Tir Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Doctor Akbar Fotoohi- Deputy Director of Research
Street address
Sixth floor, University of Medical Sciences, Central Building, Ghode street, Keshavarz boulevard-Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran 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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fateme Rahimikian
Position
Faculty member
Other areas of specialty/work
Street address
Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
F_rahimikian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences