Protocol summary

Summary
Background: Gestational diabetes is associated with a number of maternal and neonatal adverse outcomes. The prevalence of GDM has risen 122% in the last 20 years. There is evidence of bidirectional link between mental health problems and gestational diabetes. The aim of this study was to determine the effect of telephone follow up on pregnancy outcome and general health of mothers with gestational diabetes. Methods: This study was a clinical trial in which 80 mothers with gestational diabetes who were referred to prenatal clinic of Imam Khomeyni Hospital in Tehran. The inclusion criteria was include Age between 18-45 years, Singleton pregnancy, Not taking medication that increase blood glucose such as corticosteroids, Having phone at home, Not having speech and hearing problems, Being able to speak Persian language and understand it, Lack of chronic diseases, No history of infertility or ART No history of diabetes in pre pregnancy, Having at least read and write. Exclusion criteria was consist of Not respond to phone calls (more than one contact), The condition that increase blood sugar such as stress, death of relatives and take steroids and other drug, Preterm labor, Use of any diet and medication during study. They were randomly divided into intervention and control group. Data collection tools was including phone, Exicheck, demographic form, check list of telephone follow up and GHQ questionnaire. Data were collected at baseline (28 weeks of pregnancy) and 6 weeks after delivery.Telephone follow up was applied for the experimental group in the field of adherence of diet, insulin injections, lab tests and remembering later visit for 10 weeks. In addition, the questions of mothers about pregnancy, diabetes and general health were answered. Data analysis was done using SPSS and descriptive and analytic statistics (independent t-test, paired t-test, mann-whitaney and chi square) were used where appropriate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904143037N3
Registration date: 2012-06-06, 1391/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Mehrnaz Geranmayeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1669
Email address
geranmay@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2011-07-11, 1390/04/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of telephone follow up on pregnancy outcome and general health of mothers with Gestational Diabetes
Public title
Telephone Follow up and Gestational Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18-45 years Singleton pregnancy Not taking medication that increase blood glucose such as corticosteroids Having phone at home Not having speech and hearing problems Being able to speak Persian language and understand it Lack of chronic diseases No history of infertility or ART No history of diabetes in pre pregnancy Having at least read and write Exclusion Criteria: Not respond to phone calls (more than one contact) The condition that increase blood sugar such as stress, death of relatives and take steroids and other drug Preterm labor Use of any diet and medication during study
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Tehran Keshavarz Blvd Ghods Street
City
Tehran
Postal code
Approval date
2011-07-03, 1390/04/12
Ethics committee reference number
13165

Health conditions studied

1

Description of health condition studied
Gestational Diabetes
ICD-10 code
xv
ICD-10 code description
z35

Primary outcomes

1

Description
Measuring blood Sugar
Timepoint
28,32 and 36 weeks of pregnancy
Method of measurement
Exicheck

Secondary outcomes

1

Description
Outcome pregnancy and General health
Timepoint
Before and after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Telephone follow up in order to adherence to diet, insulin injections, doctor prescribed, doing lab test and also to remind the next visit and answering patient's questions about pregnancy, diabetes and generel health.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Prenatal clinic of Imam Khomeyni Hospital
Full name of responsible person
Street address
Tehran Keshavarz Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Esmat Karimi
Street address
Tehran Keshavarz Blvd ghods Street University of central building Sixth floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Science
Full name of responsible person
Mehrnaz Geranmayeh
Position
Master of Science
Other areas of specialty/work
Street address
Tehran Tohid Square Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
geranmay@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mehrnaz Geranmayeh
Position
Master of Science
Other areas of specialty/work
Street address
Tehran Tohid Square Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
geranmay@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Rezvan KhorshidiRoozbahani
Position
Master of Science
Other areas of specialty/work
Street address
Tehran Tohid Square Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
rezvan.khorshidi@gmail.com rezvan.khorshidi60@yahoo.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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