Skip to main content
OpenTrials
Completed

NCT Number: NCT00264719

Metoclopramide to Aid Establishment of Breastfeeding:a Randomised 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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 308562

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Maxalon

Placebo

Drug

placebo 10 mg

Primary outcomes

  1. successful initiation of lactation as determined by lactogenesis II markers

    Time frame: 7 days postpartum

Secondary outcomes

  1. weight change in baby 7 days after birth

    Time frame: 14 days postpartum

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

    Time frame: 6 months postpartum

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 13, 2005
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.