Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

• ClinicalTrials.gov Identifier: NCT00264719
• Recruitment Status: Completed
• First Posted: December 13, 2005
• Last Update Posted: September 21, 2009
• Sponsor: National University Hospital, Singapore
• Information provided by: National University Hospital, Singapore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding	Drug: Metoclopramide (Maxolon); Drug: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
• Study Start Date: January 2006
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. successful initiation of lactation as determined by lactogenesis II markers [ Time Frame: 7 days postpartum ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes 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:

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

Contacts and Locations

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 of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Associate Professor Chong Yap Seng, National University Hospital
• ClinicalTrials.gov Identifier: NCT00264719
• Other Study ID Numbers: NHG-SIG/05011
• First Posted: December 13, 2005
• Last Update Posted: September 21, 2009
• Last Verified: September 2009

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; Gastrointestinal Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action