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

This study has been completed.
Sponsor:
Collaborator:
The University of Western Australia
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00477776
First received: May 23, 2007
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breastfeeding
 Drug: Metoclopramide (Maxolon)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: April 2006
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: a
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
 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
Other Name: Maxalon
Placebo Comparator: b
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
 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
Active Comparator: c
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
 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
Other Name: Maxalon
Placebo Comparator: d
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
 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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477776

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
The University of Western Australia
Investigators
Principal Investigator: Chong Y S, MBBS,MRACOG National University Hospital and National University of Singapore
Principal Investigator: Citra Mattar, MBBS National University Hospital, Singapore
  More Information

Publications:

Responsible Party: Professor Chong Yap Seng, National University Hospital
ClinicalTrials.gov Identifier: NCT00477776     History of Changes
Other Study ID Numbers: NHG SIG 06022
Study First Received: May 23, 2007
Last Updated: September 18, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Beginning of breastfeeding

Additional relevant MeSH terms:
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013