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Comparing Metformin and Insulin for managemnt of Blood Sugars and Pregnancy related Outcomes in the mother and Baby in women with Gestational Diabetes.

A One-Year Randomized Trial of Metformin Versus Insulin for Glycemic Control and Maternal and Perinatal Outcomes in Gestational Diabetes. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066888
Enrollment
70
Registered
2024-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: Metformin: Metformin dosage will be calculated by endocrinologist as per glycemic status. For eg: Tab Metformin 500mg OD will be the starting dose. If Patient is attaining by good glyce

Sponsors

Dr Mrunalini Patil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant woman with diagnosed gestational diabetes (according to IADPSG criteria) needing pharmacological intervention/ anti-diabetic drugs. 2. Singleton pregnancy 3. 18 to 45 years of age 4. Gestational age of 14 to 35 weeks

Exclusion criteria

Exclusion criteria: 1. k/c/o diabetes mellitus 2. Chronic gastrointestinal disease 3. Women with gestational diabetes controlled on diet

Design outcomes

Primary

MeasureTime frame
1. Maternal outcomes like mode of delivery, association with other obstetrical disorders(like gestational hypertension, pre term delivery, etc), conversion to overt DM, etc 2. Perinatal outcomes like birth weight, congenital anomalies, neonatal hypoglycemia, Jaundice, respiratory distress, NICU admission, etcTimepoint: During pregnancy, at delivery and postpartum.

Secondary

MeasureTime frame
Glycemic control Safety profile Conversion to overt DMTimepoint: From starting of pharmacotherapy in pregnancy until 6 weeks post partum

Countries

India

Contacts

Public ContactDr Kamal Patil

Jawaharlal Nehru Medical College

kamalpatil1967@yahoo.co.in9845565454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026