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Comparing the effect of metformin with insulin on gestational diabetes

Comparison of the effect of metformin with insulin on maternal and neonatal outcomes in women with gestational diabetes

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080826001096N9
Enrollment
132
Registered
2022-10-19
Start date
2022-10-22
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Diabetes mellitus in pregnancy. Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: Administration of oral metformin 500 mg tablets (Tehran Chemie Pharmaceutical co.) once a day until the end of pregnancy. Intervention 2: Control group: Subcutaneou

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women with singletons Having gestational diabetes after 26 weeks

Exclusion criteria

Exclusion criteria: Having overt diabetes Having fasting sugar more than 120 mg/dL Having blood sugar one hour after a meal above 200 mg/dL Having chronic diseases of the digestive system Having a contraindication use for metformin

Design outcomes

Primary

MeasureTime frame
Blood sugar. Timepoint: Fasting before the intervention and one hour after the intervention weekly until the end of pregnancy. Method of measurement: Glucometer.

Secondary

MeasureTime frame
Maternal hypoglycemic episodes. Timepoint: Fasting before the intervention and one hour after the intervention weekly until the end of pregnancy. Method of measurement: Glucometer.;Blood pressure disorders in pregnancy. Timepoint: Monthly visit after the start of the intervention. Method of measurement: Sphygmomanometer.;Preterm delivery. Timepoint: Postpartum. Method of measurement: Delivery earlier than 37 weeks of pregnancy.;Intrauterine fetal death. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Absence of fetal heartbeat in ultrasound.;Polyhydramnios. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Sonography.;Macrosomia. Timepoint: Postpartum. Method of measurement: scales.;Nneonatal hypoglycemia. Timepoint: After birth. Method of measurement: Bleeding of the heel.;Shoulder dystocia. Timepoint: During childbirth. Method of measurement: Observation.;Respiratory distress syndrome. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Neonatal specialist report.;Need for Neonatal Intensive Care Unit. Timepoint: After birth. Method of measurement: Neonatal specialist report.;Metformin side effects. Timepoint: Immediately after intervention and weekly follow-up. Method of measurement: Patient report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Hajar Sharami

Rasht University of Medical Sciences

sharami@gums.ac.ir+98 13 3336 9224

Outcome results

None listed

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