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Comparison of metformin and insulin in treatment of gestational diabetes

Comparison of newborn outcomes in women with gestational diabetes treated with metformin or insulin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201104162699N5
Enrollment
200
Registered
2011-05-13
Start date
2010-11-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: for metformin group:tablet metformin 500mg,1-5daily,oral,untill end of pregnancy. Intervention 2: for insulin group : NPH and regular Insulin , 0.5 U/kg daily in 2/3morning and1/3 ni
Treatment - Drugs
for metformin group:tablet metformin 500mg,1-5daily,oral,untill end of pregnancy
for insulin group : NPH and regular Insulin , 0.5 U/kg daily in 2/3morning and1/3 night,sc,untill end of pregnancy

Sponsors

Vice Chancellor for Research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Post partum hypoglycemia. Timepoint: 3 first post partum houre. Method of measurement: Newborn blood sampling of Bs mg/dl.;Macrosomia. Timepoint: post partum. Method of measurement: Weighting of newborn ,gram with SECA scale.

Secondary

MeasureTime frame
Neonatal icter. Timepoint: until 1 week after delivery. Method of measurement: Newborn bilirubin blood sampling mg/dl.;Fetal anomaly. Timepoint: post partum. Method of measurement: Observe and physical exam of newborn.;Respiratory distress. Timepoint: until 24 hours after delivery. Method of measurement: Observe and physical exam of newborn.;Admitting to neonatal unit. Timepoint: untill 1 week after delivery. Method of measurement: admition in neonatal unit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzaneh Saberi

Kashan medical univercity/Nursing and Midwifery School

saberi_f2002@yahoo.com saberi_f@kaums.ac.ir+98 36 1555 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026