Women with GDM requiring pharmacological therapy were offered a choice of insulin or glibenclamide. Maternal and fetal outcomes were assessed in women treated with insulin or glibenclamide. The association among glyburide dose, severity of GDM, and selected maternal and neonatal factors was evaluated. Severity levels of GDM were stratified by fasting plasma glucose (FPG) from the oral glucose tolerance test (OGTT). Fetal outcomes included serious perinatal complications , admission to the NICU, jaundice requiring phototherapy, induction of labor, cesarean birth. Macrosomia was defined as birth weight>or =4000 g. The association between glyburide- and insulin-treated patients by severity of GDM and neonatal outcome was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071010876N2
Registration date:2014-06-22, 1393/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Masumeh Mirza Moradi
Name of organization / entity
Prinatalogy department of Mahdieh hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
m-bakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
infertility research center of Shahid Beheshti University
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of Gliburide and Insulin in Women With Gestational Diabetes Mellitus and Associated perinatal Outcome
Public title
Comparsion of Gliburide and Insulin in Women With Gestational Diabetes Mellitus and Associated perinatal Outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : woman with singelton pregnancy who had gdm between 24 and 36 weeks who failed diet therapy
Exclusion criteria: diabetes mellitus; medical complication, e.g.; hypertension or vascular disease; use of tobacco, alcohol; fetal anomaly.
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:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahid beheshti university
Street address
velenjak- shahidbeheshti university
City
tehran
Postal code
Approval date
2012-02-06, 1390/11/17
Ethics committee reference number
0308/14474
Health conditions studied
1
Description of health condition studied
gestational diabet
ICD-10 code
024
ICD-10 code description
Diabetes mellitus in pregnancy
Primary outcomes
1
Description
Blood glucose
Timepoint
Daily
Method of measurement
mg / dl
Secondary outcomes
1
Description
NICU admission
Timepoint
After birth
Method of measurement
Day
2
Description
Birth weight
Timepoint
After of birth
Method of measurement
gr
3
Description
Neonatal blood glucose
Timepoint
After of birth
Method of measurement
mg/ dl
4
Description
Neonatal Bilirubin
Timepoint
After birth
Method of measurement
mg/ dl
Intervention groups
1
Description
in group of intervention glyburide the therapy is usually recommended when standard dietary management dose not consistently maintain the fasting plasma glucose at <90mg/dl or the 2-hour post prandial plasma glucose <120mg/dl.
glyburide starting dose 1/25mg orally with morning meal and if necessary increase daily glyburide dose by 1/25mg Q3days in crements until maximum of 20mg /d reachd switch to insulin if 20mg /d dose not achive glucose goals those women undergo fetal testing twice weekly and serial sonography for evaluation of fetal growths.
Category
Treatment - Drugs
2
Description
in group of control insulin therapy is usually recommended when standard dietary management dose not consistently maintain the fasting plasma glucose at <90mg/dl or the 2-hour post prandial plasma glucose <120mg/dl.
a total dose of 0.4unit /kg insulin given to patient:50%NPH and 50%regular in divided dose and level of glycemic control every 2days .those women undergo fetal testing twice weekly and serial sonography for evaluation of fetal growths.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdie hospital -Shahid Beheshti University of Medical Siences
Full name of responsible person
Masoome Mirzamoradi
Street address
mahdie hospital -shoosh sq-tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
infertility research center of Shahid Beheshti University
Full name of responsible person
Dr Taheri panah
Street address
Tehran-Velenjak-Taleghani hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
infertility research center of Shahid Beheshti University
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
Shahid Beheshti University of Medical Siences
Full name of responsible person
Masoome Mirzamoradi
Position
Perinatologist
Other areas of specialty/work
Street address
mahdie hospital- shoosh sq- -tehran
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com; zfaaalpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Siences
Full name of responsible person
Masoome Mirzamoradi
Position
Perinatologist:
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Siences - Velenjak- tehran
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
zfaaalpoor@yahoo.com; drmoradi000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Siences
Full name of responsible person
Ziba Faaalpoor
Position
Resident
Other areas of specialty/work
Street address
mahdieh hospital - shoosh sq- tehran
City
Tehran
Postal code
Phone
+98 21 5506 2628
Fax
Email
zfaaalpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)