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Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

This study is currently recruiting participants.
Verified by National University Hospital, Singapore, May 2008

Sponsored by: 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

MedlinePlus related topics:   Breast Feeding   

Drug Information available for:   Metoclopramide    Metoclopramide hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study
Official Title:   Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial

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
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator
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
B: Placebo Comparator
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
C: Active Comparator
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
D: Placebo Comparator
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:

  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

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

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

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

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:

Responsible Party:   National University Hospital ( Associate Professor Chong Yap Seng )
Study ID Numbers:   NHG-SIG/05011
First Received:   December 11, 2005
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00264719
Health Authority:   Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
A drug is administered to initiate breastfeeding  

Study placed in the following topic categories:
Dopamine
Metoclopramide

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Agents
Dopamine Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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