Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo
      University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant
      women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study
      group and control group, to compare the usage of both metformin and insulin instead of using
      insulin alone. Group assignment will be randomized by computer program.
    

Detailed description: 
      A total of 80 uncontrolled diabetic pregnant patients in the 3rd trimester seeking medical
      advice in Beni-Suef University Hospital and meet the eligibility criteria, are approached
      about participation in the trial and given information pamphlets describing the study. The
      patients are asked to sign a consent form and will be assigned to one of the 2 groups: Group
      A (study group); will include 40 patients who will be treated with metformin

      (1 gm twice daily (with the 2 main meals)), combined with insulin therapy Group B (control
      group); will include 40 patients who will be treated with insulin alone. (Insulin dosage will
      be adjusted according to endocrinological recommendations) All patients will be managed
      according to NICE guidelines for diabetes with pregnancy (2015) Maternal assessment

        -  Full history taking Baseline medical history is obtained along with other baseline
           demographics and concomitant medications including insulin regimen and dose.

        -  Thorough clinical examination Maternal weight, height and blood pressure measured and
           recorded.

        -  Laboratory investigations;

             -  Routine labs: CBC, coagulation profile, liver and kidney function at time of
                participation, 28-32 weeks of gestation especially renal parameter serum
                Creatinine.

             -  HbA1c at time of 1st examination.

             -  FBS, 2h post prandial blood sugar will be done weekly from time of participation
                till time of delivery

        -  Fundus examination for early detection of retinal affection at Ophthalmology clinic

      Follow up:

        1. Fetal weight gain weekly

        2. Maternal weight gain weekly

      Accordingly:

        1. Uncontrolled cases will follow up weekly in the High Risk Pregnancy outpatient clinic
           until 36 weeks and then admitted to High risk pregnancy department for termination of
           pregnancy

           o Fetal surveillance will be done by ;CTG weekly, Ultrasound weekly and Fetal kick count
           daily

        2. Resistant uncontrolled cases will be admitted to high risk pregnancy department where
           capillary blood sugar will be measured 7 times daily Fetal surveillance will be done by
           ; CTG Daily, Ultrasound every 3 days and Fetal kick count daily

      Assessment of Patients at time of termination by:

        1. Fasting blood sugar , 2 hours post prandial blood sugar and HBA1C

        2. Routine preoperative labs. CBC, coagulation profile, liver and kidney function

        3. Fetal weight

        4. Maternal weight Neonatal assessment after delivery include the following; APGAR score,
           neonatal weight, incidence of transient tachypnea of newborn (TTN), acute respiratory
           distress syndrome (ARDS), neonatal hypoglycemia and NICU admission.
    

Intervention name(s): Metformin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): 40 patients will be treated with metformin
(1 gm twice daily (with the 2 main meals)), combined with insulin therapy; 40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment