Breastfeeding Clinical Trial
— PINSTEP-4Official title:
Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program
NCT number | NCT03589963 |
Other study ID # | 123345 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | July 13, 2021 |
Verified date | April 2022 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Parkdale Queen West Community Health Centre | Toronto | Ontario |
Canada | The Stop Community Food Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Parkdale Queen West Community Health Centre, Sprott Foundation |
Canada,
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 |
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