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

Neonatal Jaundice Clinical Trial

— BEST ABCs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043119
• Other study ID #: 20130560-01H
• Secondary ID: 13/31E
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: October 21, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Exclusive Breastfeeding Rates
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Behavioral:
• Breastfeeding Clinic

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Children's Hospital of Eastern Ontario, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post birth	No
Secondary	Rates of hyperbilirubinemia requiring phototherapy or hospitalization		6 months	No
Secondary	Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization)		24 hours - 3 months	No
Secondary	Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement)		24 hours - 3 months	No
Secondary	Breastfeeding self efficacy score (Breastfeeding Self Efficacy Scale or BSES) at 2 weeks, 1 month and 3 months		2 weeks, 1 month, 3 months	No
Secondary	Score of the Edinburgh Post-partum Depression Scale for new mothers		3 weeks	No
Secondary	Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician		2 weeks, 1 month, 3 months	No
Secondary	Number of emergency department visits for the mother and the baby		6 months	No
Secondary	Number of hospital readmissions for the mother and her baby		6 months	No
Secondary	Mothers' satisfaction with the support received		3 months	No
Secondary	Length of stay in the hospital, from delivery to discharge		2 weeks	No
Secondary	Costs associated with this community-based postpartum clinic		6 months	No