BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study (BEST ABCs)
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|ClinicalTrials.gov Identifier: NCT02043119|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 22, 2015
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 or disease||Intervention/treatment||Phase|
|Exclusive Breastfeeding Rates Neonatal Jaundice||Behavioral: Breastfeeding Clinic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||472 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||January 2015|
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|
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043119
|The Ottawa Hospital|
|Ottawa, Ontario, Canada|
|Principal Investigator:||Thierry Lacaze-Masmonteil, MD||The Ottawa Hospital|