Gestational Diabetes Mellitus in Pregnancy
Conditions
Keywords
Gestational Diabetes Mellitus, Metformin, Insulin
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
Interventions
DRUGMetformin
metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery
DRUGInsulin
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
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maternal glycemic control | From time of randomisation till 40 weeks | Maternal glycemic control was measured by blood sugar levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | at birth | \<7 at 5min |
| Neonatal intensive care unit (NICU) stay | >24 hours after birth | Admitted to NICU |
| Fetal macrosomia | at birth | Birth weight more than 4kg |
| mode of delivery | at delivery | Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery |
| Neonatal hypoglycemia | at birth | Neonatal blood sugar was checked at birth and if \<2.2mmol/l, was labelled |
| Perinatal death | 7 days of delivery | Fetal or neonatal death within 7 days |
Countries
Pakistan
Outcome results
None listed