Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial
Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 308562
- National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: A
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
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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
Other Names:
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Placebo Comparator: B
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
|
placebo 10 mg
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Active Comparator: C
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
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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
Other Names:
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Placebo Comparator: D
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
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placebo 10 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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successful initiation of lactation as determined by lactogenesis II markers
Time Frame: 7 days postpartum
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7 days postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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weight change in baby 7 days after birth
Time Frame: 14 days postpartum
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14 days postpartum
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breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery
Time Frame: 6 months postpartum
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6 months postpartum
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Collaborators and Investigators
Investigators
- Principal Investigator: Y S CHONG, MBBS, Dept. of O & G, National University Hospital
- Principal Investigator: Y S CHAN, BSN, DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL
Publications and helpful links
General Publications
- Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.
- Cregan MD, De Mello TR, Kershaw D, McDougall K, Hartmann PE. Initiation of lactation in women after preterm delivery. Acta Obstet Gynecol Scand. 2002 Sep;81(9):870-7. doi: 10.1034/j.1600-0412.2002.810913.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHG-SIG/05011
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