Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.

Detailed Description
-----------------
75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) > 5.5 mmol/l & 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily & increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin & one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied

Official Title
-----------------
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Conditions
-----------------
Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:• All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy Exclusion Criteria: Patients with Known diabetes mellitus Patients with multiple pregnancy With essential hypertension or pre eclampsia Patients having fetal malformation incompatible with life Patients with intrauterine death of fetus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br>Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery | Drug: Metformin<br>* metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery<br>* Other names: Glucophage;|
| Active Comparator: Insulin<br>Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery | Drug: Insulin<br>* The insulin group was given 3 S/C injections of regular insulin & one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery<br>* Other names: Humulin R U 100 and Humulin N;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal glycemic control | Maternal glycemic control was measured by blood sugar levels | From time of randomisation till 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal macrosomia | Birth weight more than 4kg | at birth | 
| Apgar score | <7 at 5min | at birth | 
| Neonatal intensive care unit (NICU) stay | Admitted to NICU | >24 hours after birth | 
| Perinatal death | Fetal or neonatal death within 7 days | 7 days of delivery | 
| mode of delivery | Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery | at delivery | 
| Neonatal hypoglycemia | Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled | at birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes Mellitus, Metformin, Insulin