Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Breastfeeding alone, until an infant is 6 months of age, is the best form of infant nutrition. There are many ways to help women breastfeed when they are having difficulties with the process, mostly involving support from a lactation consultant. However, some women, despite all appropriate non-medical interventions and support do not produce sufficient breast milk to meet the nutritional needs of their infant.

This is a feasibility study to determine how domperidone affects breast milk production in women with insufficient milk supply feeding term infants. This project will serve to refine and advance the design of a subsequent full-scale clinical trial.

The goal of this study is to: a) refine the intervention strategy (drug dosage), b) to define the target population and ensure adequate enrollment, c) assess protocol adherence and subject retention, and d) collect preliminary data to establish measures of clinical efficacy.

Conditions

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Insufficient Breastmilk Production

Keywords

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breastfeeding domperidone efficacy randomized controlled trial compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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domperidone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Women

* healthy women
* inadequate milk supply
* read/speak English

Infants

* healthy term infants (≥ 38 weeks gestational age)
* age ≥ 2wks and ≤3mths
* surpassed birth weight

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Katalin Ivanyi, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Stonechurch Family Health Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 32421208 (View on PubMed)

Other Identifiers

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r05-60

Identifier Type: -

Identifier Source: org_study_id