NCT00477776

Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial

Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries. Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.

Detailed description

The study aims to determine the breastfeeding initiation and duration rate of a cohort of pregnant women with gestational diabetes(diet-controlled) and insulin dependent and pre-existing diabetes, assess the impact of a post natally administered galactogogue, metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women on diet control and insulin and determine the prolactin response to lactation among diabetic women on diet control and insulin.

Conditions

• Breastfeeding

Interventions

Type	Name	Description
DRUG	Metoclopramide (Maxolon)	Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12
DRUG	Placebo	Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-09-01
• Completion: 2009-03-01
• First posted: 2007-05-24
• Last updated: 2009-09-21

Locations

1 site across 1 country: Singapore