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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Metoclopramide (Maxolon)

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Metoclopramide (Maxolon)

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Maxalon

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes