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

NCT00477776 | Completed Phase 3 DMC

• 1 other identifier: NHG SIG 06022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

Beginning of breastfeeding

Outcome Measures

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

  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

  within 6 months postpartum

Study Arms (4)

a

ACTIVE COMPARATOR

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)

b

PLACEBO COMPARATOR

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

c

ACTIVE COMPARATOR

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)

d

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Maxalon

a; c

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

b; d

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• The University of Western Australia: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (5)

• 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.

  PMID: 12225305 BACKGROUND

• 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.

  PMID: 11795051 BACKGROUND

• 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.

  PMID: 11694639 BACKGROUND

• 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.

  PMID: 15684169 BACKGROUND

• 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.

  PMID: 32421208 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Chong Y S, MBBS,MRACOG

  National University Hospital and National University of Singapore

  PRINCIPAL INVESTIGATOR

• Citra Mattar, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

SG (1)