Objective: In this randomized clinical trial the efficacy of Glibenclamide and Insulin was compared on Gestational Diabetes and outcome of pregnancy. Design and setting: In this study 80 pregnant women were recruited 40 patients (group A) will be received Insulin and 40 patients (group B) will be on Glibenclamide starting with lowest requiring does and will be increased weekly till reaching 15 mg. This study are single blind and random. Participants and intervention: Inclusion criteria: Maternal age 20-40 years old; singleton pregnancy; gestational age and diagnosis of gestational diabetes will be given during pregnancy; healthy mothers with no renal diseases liver diseases and overt diabetes.
Exclusion criteria: If the blood glucose is not controlled by the does of 15 mg Glibanclamid they will be shifted to Insulin and will be excluded the study. The primary outcome is to maintain (FBS) Fasting Blood glucose <95 mg/dl and 2 hour post prandial >120 mg/dl and intervention was about 14 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041317827N1
Registration date:2016-04-13, 1395/01/25
Registration timing:na
Last update:
Update count:0
Registration date
2016-04-13, 1395/01/25
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2006-01-21, 1384/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial on comparison of efficacy of Glibanclamide and insulin on Gestational Diabetes and outcome of pregnancy
Public title
Efficacy of Glibanclamide on Gestational diabetes and outcome of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Maternal age 20-40 years old; singleton pregnancy; gestational age and diagnosis of gestational diabetes will be given during pregnancy; healthy mothers with no renal diseases liver diseases and overt diabetes.
Exclusion criteria: If the blood glucose is not controlled by the does of 15 mg glibanclamid they will be shifted to Insulin and will be excluded the study.
Age
From 20 years old to 40 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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Cmmittee of Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
CT-P-92-6115
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
Z35.-
ICD-10 code description
high-risk pregnancy
Primary outcomes
1
Description
FBS & 2hpp
Timepoint
4 time per day: over night fast and 2 hour post parandial diet (braekfast, lunch and dinner)
Method of measurement
will be measured once a week by obestricians and twice weekly by the patients at home using Glucometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Insulin will be started , if FBS or 2hpp glucose levels are not control (FBS>95/dl and 2hpp>120mg/dl) respectively by diet control and exercise. 40 patient (group A) will be received Insulin (NPH or regular or both). The starting dose of Insulin is according to mean of their blood glucose.
Category
Treatment - Drugs
2
Description
Intervention group: 40 patients (group B) will be Glibenclamide starting with lowest requiring dose 1.25 mg (1/4 tab 5 mg) and will be increased by 1.5-2.50 mg weekly till reaching 15 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternal Fetal Medicine Research Center
Full name of responsible person
Nasrin Asadi
Street address
Zand Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Avenue
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 Of Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Lida Tahamtani
Position
Student
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
Lida.tahamtani87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Khalili Avenue
City
Shiraz
Postal code
Phone
+98 71 3628 1591
Fax
Email
nasadi2012@yahoo.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Maternal-fetal medicine research center
Full name of responsible person
Khadije Bazrafshan
Position
Master
Other areas of specialty/work
Street address
Khalili Avenue
City
Shiraz
Postal code
Phone
+98 71 3628 1591
Fax
Email
bazrafshan.kh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)