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

• ClinicalTrials.gov Identifier: NCT00477776
• Recruitment Status: Completed
• First Posted: May 24, 2007
• Last Update Posted: September 21, 2009
• Sponsor: National University Hospital, Singapore
• Collaborator: The University of Western Australia
• Information provided by: National University Hospital, Singapore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding	Drug: Metoclopramide (Maxolon); Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial
• Study Start Date: April 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 50 Years (Child, Adult)
• Sexes 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

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:

Cregan MD, De Mello TR, Kershaw D, McDougall K, Hartmann PE. Initiation of lactation in women after preterm delivery. Acta Obstet Gynecol Scand. 2002 Sep;81(9):870-7. doi: 10.1034/j.1600-0412.2002.810913.x.

Hartmann PE, Cregan MD, Mitoulas LR. Maternal modulation of specific and non-specific immune components of colostrum and mature milk. Adv Nutr Res. 2001;10:365-87. doi: 10.1007/978-1-4615-0661-4_18. No abstract available.

Hartmann P, Cregan M. Lactogenesis and the effects of insulin-dependent diabetes mellitus and prematurity. J Nutr. 2001 Nov;131(11):3016S-20S. doi: 10.1093/jn/131.11.3016S.

Hansen WF, McAndrew S, Harris K, Zimmerman MB. Metoclopramide effect on breastfeeding the preterm infant: a randomized trial. Obstet Gynecol. 2005 Feb;105(2):383-9. doi: 10.1097/01.AOG.0000151113.33698.a8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

• Responsible Party: Professor Chong Yap Seng, National University Hospital
• ClinicalTrials.gov Identifier: NCT00477776
• Other Study ID Numbers: NHG SIG 06022
• First Posted: May 24, 2007
• Last Update Posted: September 21, 2009
• Last Verified: September 2009

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; Gastrointestinal Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action