Conditions: Gestational Diabetes Mellitus in Pregnancy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: yes

Brief summary:
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Detailed description:
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

All patients were subjected to:

1. History taking:
2. General and Abdominal Examination:

   With particular emphasis on :
   * Body mass index
   * Blood pressure.
   * Fundal height .
   * Estimated fetal weight .
3. Insulin and metformin doses :

   Insulin dose:

   0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

   Metformin dose :

   Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

   If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

1. Group I: pregnant women who received oral metformin in addition to insulin therapy.
2. Group II: pregnant women who received insulin therapy only.

Arms:
arm 1: Intervention 'Insulin Mixtard' and Intervention 'metformin' had included arm 2: Intervention 'Insulin Mixtard' had included

Interventions: intervention 1: Insulin Mixtard intervention 2: Metformin
Intervention descriptions: intervention 1: Insulin dose:

* 0.7 IU/Kg (at the second trimester of pregnancy).
* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. intervention 2: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.

Protocol document: