Clinical Trial: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight

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 Summary:

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 metform
    Sponsor: Ain Shams University

    Current Primary Outcome: Glycemic control over period from 20 weeks to 36 weeks gestation [ Time Frame: from 20 weeks to 36 weeks gestation ]

    Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:

    60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient didnot reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus



    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • macrosomic baby [ Time Frame: 24 hours after delivery ]
      Fetal macrosomia has been defined birth weight greater than 4500 gm
    • Neonatal hypoglycemia [ Time Frame: 24 hours after delivery ]
      Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery


    Original Secondary Outcome: Same as current

    Information By: Ain Shams University

    Dates:
    Date Received: March 28, 2017
    Date Started: June 2016
    Date Completion:
    Last Updated: April 4, 2017
    Last Verified: April 2017