Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

• Status: Completed
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: Female

Summary

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Metformin

Criteria

Inclusion Criteria:

• Patients aged (19-35) years

• BMI 18-30 kg/m2

• Gestational age >24 weeks

• Singleton pregnancy

• Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

Exclusion Criteria:

• Pregnant women with preexisting diabetes mellitus

• Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).

• Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).

• Fetal anomalies identified on ultrasound prior to initiation of therapy.

• Patients who refused to participate