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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: The rate of exclusive breastfeeding at 3 months post-birth. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rates of hyperbilirubinemia requiring phototherapy or hospitalization [ Time Frame: 6 months ]
  • Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization) [ Time Frame: 24 hours - 3 months ]
  • Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement) [ Time Frame: 24 hours - 3 months ]
  • 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 ]
  • Score of the Edinburgh Post-partum Depression Scale for new mothers [ Time Frame: 3 weeks ]
  • Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician [ Time Frame: 2 weeks, 1 month, 3 months ]
  • Number of emergency department visits for the mother and the baby [ Time Frame: 6 months ]
  • Number of hospital readmissions for the mother and her baby [ Time Frame: 6 months ]
  • Mothers' satisfaction with the support received [ Time Frame: 3 months ]
  • Length of stay in the hospital, from delivery to discharge [ Time Frame: 2 weeks ]
  • Costs associated with this community-based postpartum clinic [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: January 21, 2014
Date Started: January 2014
Date Completion:
Last Updated: October 21, 2015
Last Verified: October 2015