Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Ain Shams University124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

124

Conditions

Gestational Diabetes

Interventions

InsulinDRUG

Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

MetforminDRUG

Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Outcomes

Primary Outcomes

Rate of maternal weight gain per week

Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.

Time frame: 4 months

Secondary Outcomes

1-min APGAR score

APGAR score at minute 1 after delivery

Time frame: 1 minute

5-min APGAR score

APGAR score at minute 5 after delivery

Time frame: 5 minutes

Incidence of neonatal hypoglycemia

Number of neonates with two or more neonatal glucose value \<2.6 mmol per liter during the first day after delivery.

Time frame: 1 day

Incidence of neonatal respiratory distress

Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery.

Time frame: 1 day

Incidence of macrosomia

Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age

Time frame: 1 hour

Data from ClinicalTrials.gov

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