NCT00264719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

December 11, 2005

Last Update Submit

September 18, 2009

Conditions

Breastfeeding

Keywords

A drug is administered to initiate breastfeeding

Outcome Measures

Primary Outcomes (1)

  • successful initiation of lactation as determined by lactogenesis II markers

    7 days postpartum

Secondary Outcomes (2)

  • weight change in baby 7 days after birth

    14 days postpartum

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

    6 months postpartum

Study Arms (4)

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)

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

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)

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

Interventions

Metoclopramide (Maxolon)DRUG

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

Also known as: Maxalon
AC
placeboDRUG

placebo 10 mg

BD

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients who have epilepsy or on anti-seizure medications,
  • Patients who have a history of significant depression or are on antidepressant drugs
  • Patients who have pheochromocytoma or uncontrolled hypertension
  • Patients who have intestinal bleeding or obstruction
  • Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
  • Patients who have diabetes and hyperprolactinaemia
  • Patients with HIV infection
  • Current pregnancy complicated by fetal congenital anomalies and multiple fetuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 308562, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 12225305RESULT

  • 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.

    PMID: 32421208DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Y S CHONG, MBBS

    Dept. of O & G, National University Hospital

    PRINCIPAL INVESTIGATOR

  • Y S CHAN, BSN

    DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2005

First Posted

December 13, 2005

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2009

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

SG(1)