Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

National University Hospital, Singapore160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Breastfeeding

Interventions

Metoclopramide (Maxolon)DRUG

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

placeboDRUG

placebo 10 mg

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria Exclusion Criteria: 1. Patients who have epilepsy or on anti-seizure medications, 2. Patients who have a history of significant depression or are on antidepressant drugs 3. Patients who have pheochromocytoma or uncontrolled hypertension 4. Patients who have intestinal bleeding or obstruction 5. Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide 6. Patients who have diabetes and hyperprolactinaemia 7. Patients with HIV infection 8. Current pregnancy complicated by fetal congenital anomalies and multiple fetuses

Locations (1)

National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

successful initiation of lactation as determined by lactogenesis II markers

Time frame: 7 days postpartum

Secondary Outcomes

weight change in baby 7 days after birth

Time frame: 14 days postpartum

breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery

Time frame: 6 months postpartum

Data from ClinicalTrials.gov

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