Because of the importance of treating gestational diabetes, this trial is performed to compare maternal and neonatal outcomes in woman with gestational diabetes mellitus (GDM) treated with either metformin or insulin.
200 women with singleton pregnancy and without history of diabetes mellitus at the age of 24-34 weeks of pregnancy are included and divided randomly in two groups including 100 women treated with insulin and 100 women treated with metformin.
Women with history of diabetes mellitus, renal or liver dysfunction and fetal growth restriction are excluded.
Insulin or metformin will be prescribed and so target capillary glucose values of 95mg/dl (fasting) and 120mg/dl (2 hours postprandial) are gained.
Data in two groups are analyzed and compared by computer methods after end of sampling. These include delivery method, apgare of 1st & 5th minute, neonatal anomalies, birth weight, and birth weight centile, hypoglycemia up to 3 hours after delivery, respiratory distress, special care baby unit and NICU admission.
General information
Acronym
GDM
IRCT registration information
IRCT registration number:IRCT201104162699N5
Registration date:2011-05-13, 1390/02/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-13, 1390/02/23
Registrant information
Name
Farzaneh Saberi
Name of organization / entity
Kashan University Of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
saberi_f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences.Vice Chancellor for Research
Expected recruitment start date
2010-11-01, 1389/08/10
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of newborn outcomes in women with gestational diabetes treated with metformin or insulin
Public title
Comparison of metformin and insulin in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational diabet in Iranian women, the age of 18-45 years, singleton pregnancy , gestational age of 24-34 weeks ,no history of previous diabetes mellitus.
Exclusion criteria:
Previous diabetes mellitus before pregnancy, liver dysfunction, renal dysfunction, intra uterine growth restriction, fetal anomaly, premature rupture of membrane, acute respiratory failure and congestive heart failure in mother
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:
200
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
kashan medicine univercity
Street address
Kashan University of Medical Sciences.kilometer of 5 Ravand way.
City
kashan
Postal code
81151-87159
Approval date
2010-12-29, 1389/10/08
Ethics committee reference number
2856/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Post partum hypoglycemia
Timepoint
3 first post partum houre
Method of measurement
Newborn blood sampling of Bs mg/dl
2
Description
Macrosomia
Timepoint
post partum
Method of measurement
Weighting of newborn ,gram with SECA scale
Secondary outcomes
1
Description
neonatal icter
Timepoint
until 1 week after delivery
Method of measurement
Newborn bilirubin blood sampling mg/dl
2
Description
Fetal anomaly
Timepoint
post partum
Method of measurement
Observe and physical exam of newborn
3
Description
Respiratory distress
Timepoint
until 24 hours after delivery
Method of measurement
Observe and physical exam of newborn
4
Description
Admitting to neonatal unit
Timepoint
untill 1 week after delivery
Method of measurement
admition in neonatal unit
Intervention groups
1
Description
for metformin group:tablet metformin 500mg,1-5daily,oral,untill end of pregnancy
Category
Treatment - Drugs
2
Description
for insulin group : NPH and regular Insulin , 0.5 U/kg daily in 2/3morning and1/3 night,sc,untill end of pregnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhani hospital
Full name of responsible person
Dr.E.Mesdaghi nia
Street address
Medical faculty,Kashan University of Medical Sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor 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
Kashan medical univercity/Nursing and Midwifery School