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BreastfeedingPINSTEP-4NCT03589963

Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

A study testing Postnatal Lactation Support in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Toronto at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Postnatal Lactation Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
2 sitesCanada
Study dates
1 Nov 2018to 13 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • CPNP clients registered prenatally
  • intention to initiate breastfeeding
  • intention to remain in Toronto with the infant for 6 months postpartum
  • willing to share contact information
  • birth at 34 weeks gestation or later

Who cannot join

  • preterm birth (below 34 weeks)
  • infant has congenital abnormality or medical condition affecting feeding
  • mother or infant still in hospital at 2 weeks postpartum

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Parkdale Queen West Community Health Centre

    Toronto, Ontario, M5V 2R4

  • The Stop Community Food Centre

    Toronto, Ontario, M6H 4E1

Other trials in Canada

About this study

Official title: Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. The CPNP strongly promotes breastfeeding prenatally, resulting in high initiation rates, but continued postnatal support is needed to optimize breastfeeding duration and exclusivity.

The aim of this research is to investigate the effects of adding postnatal lactation support as an extension to the CPNP on breastfeeding duration and exclusivity in the first six months postpartum. The research will be conducted at two CPNP sites in Toronto, Parkdale Queen West Community Health Centre and The Stop Community Food Centre. A quasi-experimental design will be used to compare the infant feeding practices of CPNP clients before and after introduction of a postnatal lactation support intervention which will include in-home professional lactation support and provision of high-quality breast pumps. These services will be delivered as CPNP program components and will be accessible to all clients at the two participating sites during the post-intervention period. Infant feeding practices will be assessed by a questionnaire administered at 2 weeks, 1, 2, 3, 4, 5 and 6 months postpartum. The hypothesis is that significantly more mothers in the post-intervention group will be exclusively breastfeeding at four months postpartum. The effect is expected to be mediated through increased breastfeeding self-efficacy, which will be assessed using validated scales prenatally and at 2 weeks and 2 months postpartum.

Being tested
Postnatal Lactation Support
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postnatal Lactation SupportBehavioural

    In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump

Study groups in NCT03589963
Study groupRoleWhat they receive
Pre-interventionNo interventionregular CPNP programming
Post-interventionExperimentalregular CPNP programming plus access to postnatal lactation support
Receives: Behavioral: Postnatal Lactation Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exclusive breastfeeding at 4 months postpartum

    Reported exclusive breastfeeding at four months postpartum assessed by a prospective infant feeding questionnaire

    Measured: birth to 4 months postpartum

Secondary outcomes (4)

  1. Duration of any breastfeeding in the first six months postpartum

    Duration of any breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire

    Measured: birth to 6 months postpartum

  2. Duration of exclusive breastfeeding in the first six months postpartum

    Duration of exclusive breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire

    Measured: birth to 6 months postpartum

  3. Age of introduction of breastmilk substitutes

    Reported timing of the introduction of breastmilk substitutes from birth to 6 months in response to a prospective infant feeding questionnaire

    Measured: birth to 6 months postpartum

  4. Age of introduction of complementary foods

    Reported timing of the introduction of complementary foods from birth to 6 months in response to a prospective infant feeding questionnaire

    Measured: birth to 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start1 Nov 2018
  3. Primary completion13 Jul 2021
  4. Study completion13 Jul 2021

Why it stopped: Institutional ORE decision to stop community based research in response to COVID emergency and need to socially distance

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589963
Sponsor's protocol ID
123345
Acronym
PINSTEP-4
Status last verified
Apr 2022
First submitted
6 Jul 2018
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, Kiss A, O'Connor DL, Sellen DW. Associations between use of expressed human milk at 2 weeks postpartum and human milk feeding practices to 6 months: a prospective cohort study with vulnerable women in Toronto, Canada. BMJ Open. 2022 Jun 8;12(6):e055830. doi: 10.1136/bmjopen-2021-055830.

    PubMed 35676013

  • Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, O'Connor DL, Sellen DW. High levels of breastmilk feeding despite a low rate of exclusive breastfeeding for 6 months in a cohort of vulnerable women in Toronto, Canada. Matern Child Nutr. 2022 Jan;18(1):e13260. doi: 10.1111/mcn.13260. Epub 2021 Aug 8.

    PubMed 34369075

  • Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Richards E, Rousseau C, Di Ruggiero E, Dennis CL, O'Connor DL, Sellen DW. Effect on breastfeeding practices of providing in-home lactation support to vulnerable women through the Canada Prenatal Nutrition Program: protocol for a pre/post intervention study. Int Breastfeed J. 2021 Jul 2;16(1):49. doi: 10.1186/s13006-021-00396-y.

    PubMed 34215288

Questions about this trial

What is this clinical trial studying?

A study testing Postnatal Lactation Support in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Institutional ORE decision to stop community based research in response to COVID emergency and need to socially distance). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exclusive breastfeeding at 4 months postpartum (time frame: birth to 4 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589963, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.

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