Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

Breastfeeding Clinical Trial

— PINSTEP-4  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03589963
• Other study ID #: 123345
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 13, 2021

Study information

• Verified date: April 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 151
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive
• Complementary Feeding
• Infant Nutrition

Intervention

Behavioral:
• Postnatal Lactation Support
In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump

Locations

Country	Name	City	State
Canada	Parkdale Queen West Community Health Centre	Toronto	Ontario
Canada	The Stop Community Food Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Parkdale Queen West Community Health Centre, Sprott Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding at 4 months postpartum	Reported exclusive breastfeeding at four months postpartum assessed by a prospective infant feeding questionnaire	birth to 4 months postpartum
Secondary	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	birth to 6 months postpartum
Secondary	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	birth to 6 months postpartum
Secondary	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	birth to 6 months postpartum
Secondary	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	birth to 6 months postpartum