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Comparing the effect of metformin versus insulin in controlling the blood sugar in of gestational diabetic mother

Compare the effect of metformin versus insulin in controlling blood sugar of gestational diabetes mellitus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016080229172N1
Enrollment
280
Registered
2017-01-06
Start date
2015-09-23
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, treatment with metformin will be started with a daily dose of 500 mg and this amount will be adjusted maximally to 1500 mg in two weeks according to blood gl
Treatment - Drugs
In the intervention group, treatment with metformin will be started with a daily dose of 500 mg and this amount will be adjusted maximally to 1500 mg in two weeks according to blood glucose
In the control group, subcutaneous injection of 0.7 IU / kg insulin will be started and increased based on blood glucose recorded daily by patients.

Sponsors

Vice Chancellor for Research of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pregnancy more than 24 weeks with gestational diabetes mellitus; singleton pregnancy; uncontrolled blood sugar with diet and exercise within a week; informed consent to participate in this project. Exclusion criteria: overt diabetes; presence of risk factors for lactic acidosis; fetal anomaly; maternal medical conditions such as kidney and liver disease; not-attending for follow up.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fast blood sugar. Timepoint: At baseline, on a daily basis until the end of pregnancy. Method of measurement: Blood sugar test / Ican glucometer, On call Model.;Blood glucose two hours after a meal. Timepoint: At baseline, on a daily basis until the end of pregnancy. Method of measurement: Blood sugar test / Ican glucometer, On call Model.

Secondary

MeasureTime frame
Type of delivery. Timepoint: Postpartum. Method of measurement: Reporting (Natural, Caesarean).;Birth weight. Timepoint: Postpartum. Method of measurement: Measuring with Germany seca Digital Scale.;Apgar score. Timepoint: Postpartum. Method of measurement: Measuring based on the standard Apgar score.;Need for NICU. Timepoint: Postpartum. Method of measurement: Reporting (have or have not).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh firouz

Mashhad University of Medical Sciences

firouzs921@mums.ac.ir+98 58 3722 3393

Outcome results

None listed

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