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

NCT ID: NCT02043119

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

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).

Conditions

Exclusive Breastfeeding Rates; Neonatal Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Breastfeeding Clinic

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

Group Type: ACTIVE_COMPARATOR

Breastfeeding Clinic

Intervention Type: BEHAVIORAL

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breastfeeding Clinic

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Lacaze-Masmonteil, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36282618 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26871448 (View on PubMed)

Other Identifiers

13/31E

Identifier Type: OTHER

Identifier Source: secondary_id

20130560-01H

Identifier Type: -

Identifier Source: org_study_id