Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Study Overview
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Brief Summary
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Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries. The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.

Detailed Description
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Hypothesis: Early Use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries. Metoclopramide(Maxolon) promotes lactation by antagonizing the release of dopamine in the central nervous system, thereby increasing prolactin levels, and thus inducing or augmenting breast milk levels. While Metoclopramide has commonly been used to augment breast milk production and relactation, its efficacy in helping to establish lactogenesis II has never been studied in a controlled clinical trial. If effective, it may become a valuable tool in aiding the successful establishment of breastfeeding, particularly in high risk groups such as mothers of preterm babies. If shown to be an effective galactogogue, the use of metoclopramide provides an inexpensive and safe means of establishing and sustaining lactogenesis II, indirectly improving the degree and duration of breastfeeding practiced by mothers of both term and preterm infants. The anticipated benefits are expected to be greatest for preterm infants and their mothers.

Official Title
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Metoclopramide to Aid Establishment of Breastfeeding After Delivery: 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 who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria Exclusion Criteria: Patients 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 Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide Patients who have diabetes and hyperprolactinaemia Patients with HIV infection Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
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>Mothers with pre-term deliveries will receive metoclopramide 10 mg three times a day for the first 7 days and 2 times a day for the 8th to 10th day, and once a day for the 11th to 12th day | Drug: Metoclopramide (Maxolon)<br>* Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day<br>* Other names: Maxalon;|
| Placebo Comparator: B<br>Mothers with pre-term deliveries will receive metoclopramide 10 mg 3 times a day, 2 times a day from 8th to 10th day and once a day from 11th to 12th day | Drug: placebo<br>* placebo 10 mg<br>|
| Active Comparator: C<br>Mothers with full term deliveries will receive 10 mg metoclopramide, 3 times a day for the first 7 days, 2 times a day from 8th to 10th day, and once a day for day 11 to 12 | Drug: Metoclopramide (Maxolon)<br>* Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day<br>* Other names: Maxalon;|
| Placebo Comparator: D<br>Mothers with full term deliveries will receive the placebo 10 mg three times a day, for 7 days, and two times a day from day 8 to day 10, and once a day from 11th to 12th day | Drug: placebo<br>* placebo 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful initiation of lactation as determined by lactogenesis II markers |  | 7 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change in baby 7 days after birth |  | 14 days postpartum | 
| breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery |  | 6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A drug is administered to initiate breastfeeding