To compare effectiveness and safety of 2 drugs used to treat gestational diabetes mellitus, one of which is oral drug, another is injectable medication.

Not Applicable

Completed

Conditions: Health Condition 1: O244- Gestational diabetes mellitus

Registration Number: CTRI/2021/10/037386

Lead Sponsor: AIIMS Jodhpur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1.Pregnant women between 18-45 years of age.

2.Singleton pregnancies at 26-30 weeks of Period of gestation.

3.Pregnant women Diagnosed with GDM according to IADPSG criteria (International association of diabetes and pregnancy study group) who failed to control on MNT only.

Exclusion Criteria

1.Contraindication to Metformin (Chronic Heart failure, Metabolic acidosis, Diabetic ketoacidosis, Severe Renal disease and pulmonary disease).

2.Medical Disorder (Chronic Hypertension, Type 1 and 2 Diabetes mellitus, Liver disease).

3.Fetal anomaly

4. Intra uterine fetal growth restriction.

5. With macrosomia and polyhydramnios

6. Fasting blood sugar =126 mg/dl and Post Prandial blood sugar = 200 mg/dl

7 . Preterm ruptured membrane. 8. Patient not giving consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess successful maternal glycemic control in Gestational Diabetes Mellitus after 2 weeks of starting the pharmacological treatment. <br/ ><br>Timepoint: from 24 weeks POG till 6 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
1.To compare HBA1c in both the groups at 36-38 week of period of gestation. <br/ ><br>2 .To compare the clinical evidence of macrosomia and polyhydramnios in pregnancies complicated by GDM on insulin or metformin. <br/ ><br>Timepoint: from 24 weeks POG till 6 weeks postpartum <br/ ><br>