Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

PHASE3CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

December 25, 2018

Study Completion Date

January 15, 2019

Conditions
Gestational Diabetes
Interventions
DRUG

Insulin

Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

DRUG

Metformin

Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

OTHER

Assessment of weight gain

Body weight will be measured monthly from the start of treatment till delivery.

Trial Locations (1)

002

Ain SHams Maternity Hospital, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT03841591 - Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin | Biotech Hunter | Biotech Hunter