NCT00284024

Brief Summary

This study is testing if a medication called domperidone will help women produce more milk so that they can keep breastfeeding and not use formula. The study is also testing what dose of domperidone works best to increase breast milk production.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 15, 2007

Status Verified

October 1, 2007

First QC Date

January 27, 2006

Last Update Submit

October 11, 2007

Conditions

Insufficient Breastmilk Production

Keywords

breastfeedingdomperidoneefficacyrandomized controlled trialcompliance

Outcome Measures

Primary Outcomes (2)

  • success of continuing breastfeeding

  • amount of supplementation used

Secondary Outcomes (4)

  • concentration of domperidone in milk

  • concentration of domperidone and prolactin in milk

  • maternal satisfaction

  • protocol adherence and barriers

Interventions

domperidoneDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • healthy women
  • inadequate milk supply
  • read/speak English
  • Infants
  • healthy term infants (≥ 38 weeks gestational age)
  • age ≥ 2wks and ≤3mths
  • surpassed birth weight

You may not qualify if:

  • Mother
  • cardiac anomalies
  • breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas)
  • medications contraindicated with domperidone use
  • drug or alcohol use
  • use of hormonal contraception
  • Infant
  • physical anomalies making breastfeeding difficult (i.e. cleft palate)
  • cardiac anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stonechurch Family Health Centre

Hamilton, Ontario, L8W 3L2, Canada

Location

Related Publications (1)

  • 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 FeedingPatient Compliance

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Katalin Ivanyi, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

September 1, 2006

Study Completion

September 1, 2007

Last Updated

October 15, 2007

Record last verified: 2007-10

Locations

CA(1)