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

Breastfeeding Clinical Trial

— Maxalon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477776
• Other study ID #: NHG SIG 06022
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2007
• Last updated: September 18, 2009
• Start date: April 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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
• 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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	The University of Western Australia

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

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. — View Citation

Hartmann P, Cregan M. Lactogenesis and the effects of insulin-dependent diabetes mellitus and prematurity. J Nutr. 2001 Nov;131(11):3016S-20S. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No