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Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264719
Enrollment
160
Registered
2005-12-13
Start date
2006-01-31
Completion date
2009-05-31
Last updated
2009-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

A drug is administered to initiate breastfeeding

Brief summary

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

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.

Interventions

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

DRUGplacebo

placebo 10 mg

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the

Design outcomes

Primary

MeasureTime frame
successful initiation of lactation as determined by lactogenesis II markers7 days postpartum

Secondary

MeasureTime frame
weight change in baby 7 days after birth14 days postpartum
breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery6 months postpartum

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026