Gestational diabetes mellitus complicates a substantial number of pregnancies. Insulin is the therapeutic agent of choice for controlling blood glucose in pregnancy.But studies have shown that metformin may have better consequences. The objective of this study was to compare maternal and neonatal outcomes in women with gestational diabetes mellitus treated with either metformin or insulin. This study used a randomized, double-blind controlled clinical trial design with two active medication conditions, which was carried out on year 2011. Subjects were chosen according to inclusion (age, gestational age, and gestational diabetes mellitus) and exclusion (contraindication for receiving metformin, history of diabetes, and serious medical condition) criteria and randomly allocated between tow groups. Metformin was started at a dose of 1000 mg daily and increased, typically over a period of two weeks, to meet glycemic targets up to a maximum daily dose of 1500 mg. Insulin was administered with an initial dose of 0.2 IU/kg/d and titrated to meet glycemic targets according to usual practice. Plasma glucose target levels were defined as fasting blood sugar (FBS) < 95 mg/dl and blood sugar (BS) 2h < 120 mg/dl. Blood sugar was recorded every two weeks up to labor time. In each visit (every two weeks) and after delivery pregnancy and neonatal outcomes in the 50 women who remained exclusively on metformin were compared with 50 women treated with insulin. The treatment was continued up to labor time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306057841N4
Registration date:2013-06-08, 1392/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-08, 1392/03/18
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Psychiatric group, Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2457
Email address
sharbafchi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2011-12-01, 1390/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Neonatal outcomes in women with gestational diabetes mellitus treated with metformin or insulin: a randomized clinical trial.
Public title
Metformin for gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) 18-45 years aged; 2) pregnancy with a single fetus between 24 and 33 weeks of gestation; 3) current diagnosis of gestational diabetes mellitus according to the criteria of the Australasian Diabetes in Pregnancy Society (ADIPS); 4) no response to lifestyle modification (diet and exercise) after one week; 5) written informed consent. Exclusion criteria: 1) any contraindication for receiving metformin (renal or hepatic failure); 2) any history or documented diagnosis of diabetes prior to pregnancy; 3) history of sever drug reaction to the drugs in study; 4) any serious medical condition that may interfere with safe study participation
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:
100
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
Isfahan University of Medical Sciences
Street address
Hezar jerib Street
City
Isfahan
Postal code
Approval date
2010-12-22, 1389/10/01
Ethics committee reference number
10/3742/د
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hyperbilirubinemia
Timepoint
During the first two hours post partum
Method of measurement
Measuring blood bilirubin
2
Description
Pregnancy Induced Hypertention
Timepoint
During pregnancy every 2 weeks
Method of measurement
Measuring blood pressure
3
Description
Neonatal hypoglycemia
Timepoint
During the first two hours post partum
Method of measurement
Measuring blood sugar
4
Description
Preterm labor
Timepoint
During pregnancy every 2 weeks
Method of measurement
Evaluating symptoms of preterm labor by physical examination and history taking
5
Description
Birtth weight
Timepoint
During the first two hours post partum
Method of measurement
Measuring Neonatal weight
6
Description
Respiratory Distress Syndrom
Timepoint
During the first two hours post partum
Method of measurement
Physical examination
Secondary outcomes
1
Description
Control of maternal hyperglycemia
Timepoint
During Pregnancy every 2 weeks
Method of measurement
Measuring fasting blood sugar and blood sugar 2h pst prandial
Intervention groups
1
Description
In metformin group, Metformin was started at a dose of 1000 mg once daily and increased, typically over a period of two weeks, to meet glycemic targets up to a maximum daily dose of 1500 mg. Plasma glucose target levels were defined as fasting blood sugar (FBS) < 95 mg/dl and blood sugar (BS) 2h < 120 mg/dl. Blood sugar was recorded every two weeks up to labor time. The treatment was continued up to labor time
Category
Treatment - Drugs
2
Description
In insulin group, insulin was administered with an initial dose of 0.2 IU/kg/d and titrated to meet glycemic targets according to usual practice. Plasma glucose target levels were defined as fasting blood sugar (FBS) < 95 mg/dl and blood sugar (BS) 2h < 120 mg/dl. Blood sugar was recorded every two weeks up to labor time. The treatment was continued up to labor time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice-Chancellery for Research
Full name of responsible person
Dr Peyman Adibi
Street address
Hezar jerib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice-Chancellery for Research
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
Isfahan University of Medical Sciences, Department of Obstetric and Gynecology
Full name of responsible person
Safie Eshaghiyan
Position
Resident of Obstetric and Gynecology
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+998 3112367004
Fax
Email
saho5557@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Department of Obstetric and Gynecology
Full name of responsible person
Safura Ruholamin
Position
Obstetric and Gynecology Specialist, Assistant Professor
Other areas of specialty/work
Street address
Hezar Jerib Street
City
Isfahan
Postal code
Phone
+98 31 1236 7004
Fax
Email
s_rouholamin@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi Zadeh
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
Sharbafchi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)