Official Title: “Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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
• 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
• 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

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National University Hospital, Singapore

Overall Clinical Trial Officials and Contacts

Chong Y S, MBBS,MRACOG Principal Investigator National University Hospital and National University of Singapore  

Overall Contact: Chong Y S, MBBS,MRACOG 67724272 obgcys@nus.edu.sg

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00477776

Study ID Number: NHG SIG 06022

ClinicalTrials.gov Identifier: NCT00477776

Health Authority: Singapore: Health Sciences Authority