Exclusive Breastfeeding RatesBEST ABCsNCT02043119
BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study
A study testing Breastfeeding Clinic in people with Exclusive Breastfeeding Rates and Neonatal Jaundice, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Exclusive Breastfeeding Rates, Neonatal Jaundice
- What is being tested?
- Breastfeeding Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers having delivered a baby at The Ottawa Hospital - General or Civic Campus:
- Who are ≥ 18 years at the time of enrollment
- Who are any parity, with a singleton infant born > 36 + 6 weeks of Gestational Age
- 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
- Who are breastfeeding and intend to breastfeed their baby upon discharge
- 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
- Who can be contacted by phone or E-mail after hospital discharge
Who cannot join
- Mothers:
- Who have had breast surgery
- Who do not understand French or English
- Who are unable to present to the clinic (transport not available)
- Who have birthed multiples or preterm
- Whose infants are exclusively formula-fed
- Who are adoptive mothers
- Who have been identified with a psychological risk that may impede her ability to attend the first appointment at the clinic
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Breastfeeding Clinic
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding ClinicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Clinic | Active comparator | A breastfeeding clinic that mothers can attend with their infants up to one month post delivery. Receives: Behavioral: Breastfeeding Clinic |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post birth
Secondary outcomes (11)
Rates of hyperbilirubinemia requiring phototherapy or hospitalization
Measured: 6 months
Poor infant weight gain requiring intervention (pumping, supplementation, hospitalization)
Measured: 24 hours - 3 months
Incidence of breastfeeding difficulties (e.g., sore nipples, insufficient milk supply, inadequate latch, engorgement)
Measured: 24 hours - 3 months
Breastfeeding self efficacy score (Breastfeeding Self Efficacy Scale or BSES) at 2 weeks, 1 month and 3 months
Measured: 2 weeks, 1 month, 3 months
Score of the Edinburgh Post-partum Depression Scale for new mothers
Measured: 3 weeks
Access to community-based services: Public Health Clinics, Family Doctor, Pediatrician
Measured: 2 weeks, 1 month, 3 months
Number of emergency department visits for the mother and the baby
Measured: 6 months
Number of hospital readmissions for the mother and her baby
Measured: 6 months
Mothers' satisfaction with the support received
Measured: 3 months
Length of stay in the hospital, from delivery to discharge
Measured: 2 weeks
Costs associated with this community-based postpartum clinic
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exclusive Breastfeeding RatesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Thierry Lacaze-Masmonteil, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043119
- Sponsor's protocol ID
- 20130560-01H
- Other IDs
- 13/31E
- Acronym
- BEST ABCs
- Status last verified
- Oct 2015
- First submitted
- 21 Jan 2014
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36282618Laliberte 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.
PubMed 26871448
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study
- ClinicalTrials.gov ID
- NCT02043119
- Acronym / sponsor ID
- BEST ABCs / 20130560-01H
- Conditions
- Exclusive Breastfeeding Rates, Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario, Ontario Ministry of Health and Long Term Care
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Clinic | Active comparator | Behavioral: Breastfeeding ClinicA breastfeeding clinic that mothers can attend with their infants up to one month post delivery. |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mothers having delivered a baby at The Ottawa Hospital - General or Civic Campus:
Key exclusion criteria (8 listed)
- Mothers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding Clinic | Behavioural | Breastfeeding Clinic |
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.
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 36282618Gavine 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.
- Derived from this study: PubMed 26871448Laliberte 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.
Related trials for Exclusive Breastfeeding Rates
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Lacaze-Masmonteil, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Clinic in people with Exclusive Breastfeeding Rates and Neonatal Jaundice, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of exclusive breastfeeding at 3 months post-birth. (time frame: 3 months post birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.