Full Text View
Tabular View
No Study Results Posted
Related Studies
Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial
This study has been completed.
Study NCT00264719   Information provided by National University Hospital, Singapore
First Received: December 11, 2005   Last Updated: September 18, 2009   History of Changes

December 11, 2005
September 18, 2009
January 2006
May 2008   (final data collection date for primary outcome measure)
successful initiation of lactation as determined by lactogenesis II markers [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00264719 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
 
Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial
Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study
Breastfeeding
  • Drug: Metoclopramide (Maxolon)
  • Drug: placebo
  • 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
  • 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
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
160
May 2009
May 2008   (final data collection date for primary outcome measure)

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
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00264719
Associate Professor Chong Yap Seng, National University Hospital
NHG-SIG/05011
National University Hospital, Singapore
 
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
National University Hospital, Singapore
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP