Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Condition(s) targeted: Breastfeeding

Intervention: Metoclopramide (Maxolon) (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National University Hospital, Singapore

Official(s) and/or principal investigator(s):
Y S CHONG, MBBS, Principal Investigator, Affiliation: Dept. of O & G, National University Hospital
Y S CHAN, BSN, Principal Investigator, Affiliation: DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL

Overall contact:
Doris LOH, B.A, IBCLC, Phone: 96387660, Email: dorisdeborah@yahoo.com

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study

Primary outcome: successful initiation of lactation as determined by lactogenesis II markers

Secondary outcome:

weight change in baby 7 days after birth

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

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Doris LOH, B.A, IBCLC, Phone: 96387660, Email: dorisdeborah@yahoo.com

National University Hospital, Singapore 308562, Singapore; Recruiting
Chong Yap Seng, MBBS, Phone: (65)67724286, Email: obgcys@nus.edu.sg
Fok Doris, IBCLC, Phone: (65)67724260, Email: dorisdeborah@yahoo.com
Y S Chan, BSN, Principal Investigator
Citra N Mattar, MBBS, Sub-Investigator
Mary Rauff, MBBS, Sub-Investigator
Mark D Cregan, Sub-Investigator

Starting date: January 2006
Ending date: May 2009
Last updated: May 12, 2008