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Metformin is more effective than insulin in treating gestational diabetes

Comparing of the effectiveness of insulin and metformin in treating gestational diabetes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014010116025N1
Enrollment
400
Registered
2014-05-18
Start date
2014-01-28
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. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: In the metformin group, the treatment will begin with 500 mg of metformin (produced by Apotex company, holding the trademark
Apo Metfromin). It will be given once or twice a day starting with meals so that within a 1 to 2 week’s time the target blood glucose is reached or to the maximum level of 2500 mg of daily dosage it w
Treatment - Drugs
In the metformin group, the treatment will begin with 500 mg of metformin (produced by Apotex company, holding the trademark
Insulin will be used in a 0.5 to 1 unit/kg dosage dependent on the pregnancy age (in the 1st trimester: 0.5 unit/kg, 2nd trimester: 0.7 unit/kg and the 3rd trimester: 1 unit/kg). According to the Mult

Sponsors

Vice Chancellor for Research and Technology, Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age ranging from 18 to 45; affliction with gestational diabetes according to the criteria pinpointed by Australian Diabetes in Pregnancy Society (ADIPS); pregnancy with a single embryo; 20th to 32th week of pregnancy; meeting the hospital’s common criteria concerning the beginning of insulin (after the diet intervention and physical exercises their capillary blood glucose after an overnight fast should be above 90 mg/dl or their 2hpp blood glucose measurement should be above 120.6 d.l.). Exclusion criteria: pre-pregnancy diabetes; metformin consumption; embryonic anomaly; hypertensive pregnancy disorders; pre-eclampsia; embryonic growth restriction and premature rupture.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Maternal blood glucose control. Timepoint: During pregnancy: every 2 weeks. Method of measurement: During pregnancy: every 2 weeks.

Secondary

MeasureTime frame
Birth weight. Timepoint: 2 hour after delivery. Method of measurement: Neonatal weight measurement.;Birth height. Timepoint: 2 hour after delivery. Method of measurement: Baby Height gauges.;Head circumference. Timepoint: 2 hour after delivery. Method of measurement: With using meter.;Chest circumference. Timepoint: 2 hour after delivery. Method of measurement: With using meter.;First minute apgar. Timepoint: One minute after delivery. Method of measurement: Apgar score.;Fiftt minute apgar. Timepoint: Five minutes after delivery. Method of measurement: Apgar score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mojgan Rahbar

Hormozgan University of Medical Sciences

rahbar_mojgan@yahoo.com+98 917 739 7863

Outcome results

None listed

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