Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in motheres 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)

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

Primary Outcomes: a. successful initiation of lactation as determined by lactogenesis II markers.; b. successful initation of lactation as determined by maternal perception; c. timing of successful establishment of lactogenesis II
Secondary Outcomes: a. amount of colostrum and breast milk fed to the neonate directly from the breast as determined by test weighing of the neonate.; b.volume of colostrum and breast milk expressed and fed to the neonate; c.total amount of colostrum and breastmilk fed to the neonate either directly or by expression.; d. weight change in baby 7 days after birth; e. breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery
Expected Total Enrollment:  160

Hypothesis:

Early Use of oral metoclopramide can hasten and improve the establishment of lactogensis II in mothers after preterm and term deliveries.

Metoclopramide(Maxolon) promotes lactation by antagonizing the release of dopamine in the central nervous system, therby increasing prolactin levels, and thus inducing or augmenting breastmilk levels. While Metoclopramide has commonly been used to augment breastmilk production and relactation, its efficacy in helping to establish lactoenesis 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.

Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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 hae a history of significant depression or are on antidepressant drugs
3. patients who have pheochromocytoma or uncontrolled hyptertension
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 -

Please refer to this study by ClinicalTrials.gov identifier  NCT00264719

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

Singapore
      National University Hospital, Singapore,  308562,  Singapore

Study chairs or principal investigators

Y S CHONG, MBBS,  Principal Investigator,  Dept. of O & G, National University Hospital   
Y S CHAN, BSN,  Principal Investigator,  DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL   

Study ID Numbers:  NHG-SIG/05011
Last Updated:  December 12, 2005
Record first received:  December 11, 2005
ClinicalTrials.gov Identifier:  NCT00264719
Health Authority: Singapore: National Healthcare Group Domain Specific Revew Board
ClinicalTrials.gov processed this record on 2006-01-10