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

Study Overview
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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.

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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Drug: Metoclopramide (Maxolon)
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a<br>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 | Drug: Metoclopramide (Maxolon)<br>* 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<br>* Other names: Maxalon;|
| Placebo Comparator: b<br>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 | Drug: Placebo<br>* 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<br>|
| Active Comparator: c<br>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 | Drug: Metoclopramide (Maxolon)<br>* 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<br>* Other names: Maxalon;|
| Placebo Comparator: d<br>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 | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beginning of breastfeeding