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Completed

NCT Number: NCT00477776

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

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide (Maxolon)

Drug

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

Other names: Maxalon

Placebo

Drug

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

Primary outcomes

  1. a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II

    Time frame: within the first two weeks postpartum

Secondary outcomes

  1. amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months

    Time frame: within 6 months postpartum

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • The University of Western Australia

Registry information

Official study title

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

Acronym: Maxalon

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
May 24, 2007
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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