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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT02043119
First received: January 21, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Exclusive Breastfeeding Rates
Neonatal Jaundice
Behavioral: Breastfeeding Clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • The rate of exclusive breastfeeding at 3 months post-birth. [ Time Frame: 3 months post birth ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization) [ Time Frame: 24 hours - 3 months ] [ Designated as safety issue: No ]
  • Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement) [ Time Frame: 24 hours - 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Score of the Edinburgh Post-partum Depression Scale for new mothers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician [ Time Frame: 2 weeks, 1 month, 3 months ] [ Designated as safety issue: No ]
  • Number of emergency department visits for the mother and the baby [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of hospital readmissions for the mother and her baby [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mothers' satisfaction with the support received [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of stay in the hospital, from delivery to discharge [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Costs associated with this community-based postpartum clinic [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Breastfeeding Clinic
A breastfeeding clinic that mothers can attend with their infants up to one month post delivery.
Behavioral: Breastfeeding Clinic
No Intervention: Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043119

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Children's Hospital of Eastern Ontario
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Thierry Lacaze-Masmonteil, MD The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02043119     History of Changes
Other Study ID Numbers: 20130560-01H, 13/31E
Study First Received: January 21, 2014
Last Updated: March 10, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 26, 2014