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

Phase 3

Completed

• Conditions: Breastfeeding
• Interventions: Drug: Metoclopramide (Maxolon); Drug: Placebo

• Registration Number: NCT00477776
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2008-09
• Study Completion: 2009-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• All pregnant women with pregestational or gestational diabetes under diet or insulin control

Exclusion Criteria

• Patient who have epilepsy or on anti-seizure medications,
• Patients who have a history of significant depression or are on antidepressant drugs
• Patients who have pheochromocytoma or uncontrolled hypertension
• Patients who have intestinal bleeding or obstruction
• Patient with known allergy or prior reaction to metoclopramide
• Patient with HIV infection
• Current pregnancy complicated by fetal congenital anomalies and multiple fetuses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a	Metoclopramide (Maxolon)	Mother with diet-controlled diabetes receive Metoclopramide 10 mg 3 times a day for the first 7 days, and 2 times a day for day 8 to 10, and once a day from day 11 to day 12
c	Metoclopramide (Maxolon)	Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day from day 11 to 12
b	Placebo	Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day for day 11 to 12
d	Placebo	Placebo 10 mg 3 times a day for 7 days, 2 times a day for day 8 to 10; and once a day from day 11 to 12

Primary Outcome Measures

Name	Time	Method
a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II	within the first two weeks postpartum

Secondary Outcome Measures

Name	Time	Method
amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months	within 6 months postpartum

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore