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Metformin in the management of gestational diabetes mellitus

Metformin compared with insulin in control of blood sugar in gestational diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201105075591N2
Enrollment
160
Registered
2011-05-31
Start date
2010-12-06
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 arising in pregnancy

Interventions

Intervention 1: In the intervention group, metformin 500 mg tablet was given twice a day to a maximum of 2500 mg/day based on glycemic profile that begins from 20 to 34 weeks gestational age and conti
Treatment - Drugs
In the intervention group, metformin 500 mg tablet was given twice a day to a maximum of 2500 mg/day based on glycemic profile that begins from 20 to 34 weeks gestational age and continue throughout o
In the control group, insulin 0.5 IU / kg as subcutaneous injection was started and titrated based on plasma glucose values from gestational age of 20 to 34 weeks and continue throughout of pregnancy.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1 - 18 to 40 years old pregnant women 2 - Singleton Pregnancy 3 - gestational age between 20 to 34 weeks (based on reliable LMP or ultrasound before 20 weeks of gestation) 3 - Diagnosis of GDM based on 2 or more abnormal values in GTT as per Carpenter and Coustan's criterion. Exclusion criteria: 1 - Systemic underlying disease (cardiovascular, pulmonary, renal , liver and autoimmune) 2 - Substance Abuse 3- Overt diabetes mellitus (except previous history of GDM)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Plasma glucose. Timepoint: twice a week. Method of measurement: laboratory (mg/dl).

Secondary

MeasureTime frame
Preeclampsia. Timepoint: Antenatal and postpartum. Method of measurement: blood pressure (mmhg),proteinuria (mg/dl).;Preterm delivery. Timepoint: postnatal. Method of measurement: gestational age (week).;Cesarean section. Timepoint: tim of delivery. Method of measurement: mode of delivery.;Perinatal mortality. Timepoint: antenatal,neonatal period. Method of measurement: IUFD,Still birth,neonatal death.;Macrosomia. Timepoint: birth time. Method of measurement: birth weight(kg).;Hypoglycemia. Timepoint: 1st 24hr after birth. Method of measurement: laboratory (mg/dl).;NICU admission. Timepoint: neonatal period. Method of measurement: day.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azin Alavi

Tehran University of Medical Sciences

alavi-a@razi.tums.ac.ir+98 21 8889 7764

Outcome results

None listed

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