The purpose of this study is to compare the effects of insulin and Glibenclamide in treating gestational diabetes mellitus. A total of 88 pregnant women with gestational diabetes mellitus who came to Imam Reza hospital are recruited an 18 months study. The patients are randomly allocated into insulin or Glibenclamide group. The patients in insulin group receive 0.5 unit/kg subcutaneous insulin twice a day: 2/3 in the morning and 1/3 in the evening. Insulin dose is increased weekly if it is necessary. In Glibenclamide group, patients receive 2.5 mg oral Glibenclamide then its dose is increased 5mg per week up to getting the maximum dose of 20mg per day. Pregnant women are taught how to use the Glucometer. Their blood sugar is measured in each visit by the gynecologist weekly, as well. Primary outcome: blood glucose level. Secondary outcomes: fetal disorders such as: macrosomia, oligohydrominus, polyhydrominous, intrauterine fetal death, intrauterine retardation, fetal abnormalities, Apgar score at birth, hypoglycemia, hypocalcemia and infants bed ridden in NICU and also maternal outcomes such as cesarean section rate and pre-eclampcia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010203797N2
Registration date:2010-12-01, 1389/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Maryam Zangene
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1721 4133
Email address
mzangene@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-04-09, 1389/01/20
Expected recruitment end date
2011-09-11, 1390/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of therapeutic effects of insulin and Glibenclamide in the gestational diabetes mellitus
Public title
Comparing the effects of Insulin and Glibenclamide in treating gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single pregnancy with gestational age between 11-33 weeks
Exclusion criteria: patient's disagreement, multi pregnancy, history of pre-pregnancy diabetes, infectious disease, cardiovascular diseases, agglutination disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
N/A
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
Kermanshah University of Medical Sciences
Street address
#2 building, Kermanshah university of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
6714415333
Approval date
2010-03-01, 1388/12/10
Ethics committee reference number
1/p/1.33918
Health conditions studied
1
Description of health condition studied
Diabetes in pregnancy
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
blood glucose level
Timepoint
4 times a day (being fast, 2h after breakfast, 2h after lunch, 2h after dinner
Method of measurement
daily recording by patient, weekly measuring in ever visit
Secondary outcomes
1
Description
fetal disorders such as macrosomia,
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
2
Description
oligohydroaminus
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
3
Description
determination of polyhydroaminous
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
4
Description
determination of intrauterine fetal death
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
5
Description
determination of intrauterine retardation frequency
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
6
Description
determination of fetal abnormalities
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
7
Description
determination of apgar at birth
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
8
Description
hypoglycemia
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
9
Description
hypoglylcemia
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
10
Description
infants bedridden in NICU
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
11
Description
cesarean section frequency
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
12
Description
pre-eclampcia frequency
Timepoint
during and after birth
Method of measurement
laboratory works and usual tests for newborns
Intervention groups
1
Description
Insulin (100units/ vial, Eksir co, Iran) 0.5 unit/kg subcutaneous twice a day: 2/3 in the morning and 1/3 in the evening. Insulin dose is increased weekly if it is necessary.
Category
Treatment - Drugs
2
Description
Glibenclamid (tablet 5mg, Kimia Daroo, Iran), 2.5 mg oral then its dose is increased 5mg per week up to getting the maximum dose of 20mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Maryam Zangeneh
Street address
#2 building, Kermanshah university of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah university of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
#2 building, Kermanshah university of Medical Sciences, Shahid Beheshti
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Assistant professor/ gynecologist
Other areas of specialty/work
Street address
#2 building, Kermanshah university of Medical Sciences, Shahid Beheshti
City
Kermanshah
Postal code
67344_15333
Phone
+98 83 1433 4157
Fax
+98 83 1433 4157
Email
mzangene@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Assistant professor/ gynecologist
Other areas of specialty/work
Street address
#2 building, Kermanshah university of Medical Sciences, Shahid Beheshti
City
Kermanshah
Postal code
Phone
+98 84 1433 4157
Fax
+98 83 1433 4157
Email
mzangene@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Assistant professor/ gynecologist
Other areas of specialty/work
Street address
Kermanshah university of Medical Sciences #2 building/ Shahid Beheshti Boulevard
City
Kermanshah
Postal code
67344_15333
Phone
+98 83 1433 4157
Fax
+98 43 34667
Email
mzangene@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)