A clinical trial to to compare pregnancy outcome in women with diabetes and poly cystic ovarin syndrome ( PCOS) treated with metformin

A Comparative trial of metformin versus Insulin in Pregnant women with diabetes Mellitus and to evaluate the role of metformin in PCOS conceptions.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000709

Enrollment

200

Registered

2009-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Metformin 500mg: three times a day- dose adjustment based on response till delivery Control Intervention1: Insulin - Mixtard/ actrapid: dose adjusted to blood glucose response

Eligibility

Inclusion criteria

Inclusion criteria: gestational diabetes women who failed diet therapy in pregnancy

Exclusion criteria

Exclusion criteria: Women with hypertension, Type 1 diabetes mellitus, Liver/ kidney function impaired

Design outcomes

Primary

Measure	Time frame
Blood sugar control through out pregnancyTimepoint: till delivery	—

Secondary

Measure	Time frame
Baby weight, Shoulder dystocia Neonatal Morbidity- Hypoglycemia, Hyperbilirubenemia, electrolyte imbalance, Respiratory DistressTimepoint: till 7th neonatal day	—

Countries

India

Contacts

Public ContactMeenakshi Dua

Manipal University

railavanya@yahoo.com09448296689

Outcome results