Breastfeeding
Conditions
Keywords
Beginning of breastfeeding
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.
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.
Interventions
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
DRUGPlacebo
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
Sponsors
The University of Western Australia
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Singapore
Outcome results
None listed