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BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study (BEST ABCs)

Primary Purpose

Exclusive Breastfeeding Rates, Neonatal Jaundice

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Breastfeeding Clinic
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Exclusive Breastfeeding Rates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mothers having delivered a baby at The Ottawa Hospital - General or Civic Campus:

    1. Who are ≥ 18 years at the time of enrollment
    2. Who are any parity, with a singleton infant born > 36 + 6 weeks of Gestational Age
    3. Who have no medical counter indication for discharge at 24 (±12) hours post vaginal delivery or 48 (±12) hours post C-section delivery and for which the physician (family physician or obstetrician) has agreed that the mother is eligible
    4. Who are breastfeeding and intend to breastfeed their baby upon discharge
    5. Whose infant is healthy with no counter indication for discharge at 24 (±12) hours post vaginal birth or 48 (±12) hours post C-section birth and for which the physician (family physician or paediatrician) has agreed that the infant is eligible
    6. Who can be contacted by phone or E-mail after hospital discharge

Exclusion Criteria:

  • Mothers:

    1. Who have had breast surgery
    2. Who do not understand French or English
    3. Who are unable to present to the clinic (transport not available)
    4. Who have birthed multiples or preterm
    5. Whose infants are exclusively formula-fed
    6. Who are adoptive mothers
    7. Who have been identified with a psychological risk that may impede her ability to attend the first appointment at the clinic

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Breastfeeding Clinic

Standard of Care

Arm Description

A breastfeeding clinic that mothers can attend with their infants up to one month post delivery.

Outcomes

Primary Outcome Measures

The rate of exclusive breastfeeding at 3 months post-birth.
The rate of exclusive breastfeeding at 3 months post-birth. We define exclusive breastfeeding as the feeding of the infant's mother's milk only for at least 2 weeks prior to collected outcome.

Secondary Outcome Measures

Rates of hyperbilirubinemia requiring phototherapy or hospitalization
Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization)
Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement)
Breastfeeding self efficacy score (Breastfeeding Self Efficacy Scale or BSES) at 2 weeks, 1 month and 3 months
Score of the Edinburgh Post-partum Depression Scale for new mothers
Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician
Number of emergency department visits for the mother and the baby
Number of hospital readmissions for the mother and her baby
Mothers' satisfaction with the support received
Length of stay in the hospital, from delivery to discharge
Costs associated with this community-based postpartum clinic

Full Information

First Posted
January 21, 2014
Last Updated
October 21, 2015
Sponsor
Ottawa Hospital Research Institute
Collaborators
Children's Hospital of Eastern Ontario, Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT02043119
Brief Title
BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study
Acronym
BEST ABCs
Official Title
BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Children's Hospital of Eastern Ontario, Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, healthy mothers willing to breastfeed their babies are discharged from the hospital on an average 2 days after a vaginal delivery or 3.5 days after a C-section, at a time where breastfeeding is far to be well established. Following discharge, women can access breastfeeding support from Public Health Units, lactation consultants, health care providers, and Internet (e.g. from breastfeeding associations). Despite the current support, duration and exclusivity rates of breastfeeding drop precipitously in the first weeks and months after birth. We have obtained funding from the Ontario Ministry of Health and Long Term Care to evaluate the efficacy and cost effectiveness of a post-partum clinic based in the community. This clinic, staffed by a family physician (in the morning), a registered nurse and a lactation consultant, will provide breastfeeding support during the first month after delivery as well as ensure a safe transition from hospital to the community for mothers and newborn babies. The clinic, affiliated with TOH, will be found at Harmony Medical Centre, 152 Cleopatra Drive, located south-west of downtown, a 15 minute drive from the Civic campus and 20 minutes from the General campus. The Harmony Clinic has abundant parking (free on the street or a small fee inside the associated lot) and is fully accessible. In its initial phase, the future clinic would enroll only women willing to participate in a research program to evaluate this new program. The clinic will be opening in November 2013 and currently (July - October 2013) we are conducting a pilot study to test feasibility of recruitment and test the surveys and database for this project. Women will be recruited at the Ottawa Hospital (General and Civic campus) and randomized to either receive standard-care or to be given access to the post-partum clinic and be discharged within approximately 24 hours following a vaginal delivery or 48 hours following a C-section. They will have an appointment booked at the breastfeeding clinic within 48 hours after discharge for maternal and neonatal care as well as breastfeeding support. Enrolled women will have access to additional clinic visits for one month after delivery. Information will be collected from their medical chart as well as through surveys that will be sent to them at 15 days, 30 days and 3 months after delivery. We will compare the data and information on the experience of women who attended the breastfeeding clinic and those who did not attend the clinic. With this data we will be able to determine if this type of breastfeeding clinic is beneficial to new mothers and their newborn babies and if it really does increase the exclusive breastfeeding rate at 3 months (primary outcome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exclusive Breastfeeding Rates, Neonatal Jaundice

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding Clinic
Arm Type
Active Comparator
Arm Description
A breastfeeding clinic that mothers can attend with their infants up to one month post delivery.
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Breastfeeding Clinic
Primary Outcome Measure Information:
Title
The rate of exclusive breastfeeding at 3 months post-birth.
Description
The rate of exclusive breastfeeding at 3 months post-birth. We define exclusive breastfeeding as the feeding of the infant's mother's milk only for at least 2 weeks prior to collected outcome.
Time Frame
3 months post birth
Secondary Outcome Measure Information:
Title
Rates of hyperbilirubinemia requiring phototherapy or hospitalization
Time Frame
6 months
Title
Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization)
Time Frame
24 hours - 3 months
Title
Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement)
Time Frame
24 hours - 3 months
Title
Breastfeeding self efficacy score (Breastfeeding Self Efficacy Scale or BSES) at 2 weeks, 1 month and 3 months
Time Frame
2 weeks, 1 month, 3 months
Title
Score of the Edinburgh Post-partum Depression Scale for new mothers
Time Frame
3 weeks
Title
Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician
Time Frame
2 weeks, 1 month, 3 months
Title
Number of emergency department visits for the mother and the baby
Time Frame
6 months
Title
Number of hospital readmissions for the mother and her baby
Time Frame
6 months
Title
Mothers' satisfaction with the support received
Time Frame
3 months
Title
Length of stay in the hospital, from delivery to discharge
Time Frame
2 weeks
Title
Costs associated with this community-based postpartum clinic
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mothers having delivered a baby at The Ottawa Hospital - General or Civic Campus: Who are ≥ 18 years at the time of enrollment Who are any parity, with a singleton infant born > 36 + 6 weeks of Gestational Age Who have no medical counter indication for discharge at 24 (±12) hours post vaginal delivery or 48 (±12) hours post C-section delivery and for which the physician (family physician or obstetrician) has agreed that the mother is eligible Who are breastfeeding and intend to breastfeed their baby upon discharge Whose infant is healthy with no counter indication for discharge at 24 (±12) hours post vaginal birth or 48 (±12) hours post C-section birth and for which the physician (family physician or paediatrician) has agreed that the infant is eligible Who can be contacted by phone or E-mail after hospital discharge Exclusion Criteria: Mothers: Who have had breast surgery Who do not understand French or English Who are unable to present to the clinic (transport not available) Who have birthed multiples or preterm Whose infants are exclusively formula-fed Who are adoptive mothers Who have been identified with a psychological risk that may impede her ability to attend the first appointment at the clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lacaze-Masmonteil, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36282618
Citation
Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
Results Reference
derived
PubMed Identifier
26871448
Citation
Laliberte C, Dunn S, Pound C, Sourial N, Yasseen AS 3rd, Millar D, Rennicks White R, Walker M, Lacaze-Masmonteil T. A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads. PLoS One. 2016 Feb 12;11(2):e0148520. doi: 10.1371/journal.pone.0148520. eCollection 2016.
Results Reference
derived

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BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study

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