Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial - Full Text View

Sponsor:	National University Hospital, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00264719

Purpose

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.

Condition	Intervention
Breastfeeding	Drug: Metoclopramide (Maxolon) Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding

Drug Information available for: Metoclopramide hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:

successful initiation of lactation as determined by lactogenesis II markers [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

weight change in baby 7 days after birth [ Time Frame: 14 days postpartum ] [ Designated as safety issue: No ]
breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2006
Study Completion Date:	May 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: Metoclopramide (Maxolon) 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 Name: Maxalon
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	Drug: placebo placebo 10 mg
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	Drug: Metoclopramide (Maxolon) 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 Name: Maxalon
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	Drug: placebo placebo 10 mg

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264719

Locations

Singapore
National University Hospital
Singapore, Singapore, 308562

Sponsors and Collaborators

National University Hospital, Singapore

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

More Information

Publications:

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.

Responsible Party:	Associate Professor Chong Yap Seng, National University Hospital
ClinicalTrials.gov Identifier:	NCT00264719 History of Changes
Other Study ID Numbers:	NHG-SIG/05011
Study First Received:	December 11, 2005
Last Updated:	September 18, 2009
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:

A drug is administered to initiate breastfeeding

Additional relevant MeSH terms:

Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012