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

National University Health System (NUHS)

Status and phase

Completed

Phase 3

Conditions

Breastfeeding

Treatments

Drug: Placebo

Drug: Metoclopramide (Maxolon)

Study type

Interventional

Funder types

Other

Identifiers

NCT00477776

NHG SIG 06022

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

Female

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 4 patient groups, including a placebo group

Active Comparator group

Description:

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

Treatment:

Drug: Metoclopramide (Maxolon)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Metoclopramide (Maxolon)