BreastfeedingNCT01893736
Professional Breastfeeding Support Intervention
A study testing In-hospital professional support and Postpartum telephone follow-up support in people with Breastfeeding, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial summary
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- In-hospital professional support and Postpartum telephone follow-up support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 4 sitesHong Kong
- Study dates
- Sep 2010to Mar 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- delivers at participating trial site,
- primiparous,
- intends to breastfeed,
- 18 years of age or older,
- has singleton pregnancy,
- Cantonese speaking,
- Hong Kong resident for more than one year,
- no serious medical or obstetrical complications
Who cannot join
- < 37 weeks gestation,
- an Apgar score < 8 at five minutes,
- a birth weight < 2500 grams,
- born with any severe medical conditions or congenital malformations,
- is placed in the special care nursery for more than 48 hours after delivery,
- is placed in the intensive care nursery after delivery,
- not entitled to health benefits in Hong Kong (NEP).
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Kwong Wah Hospital
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official title: A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
Read the detailed description
The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.
The primary hypotheses are:
- Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
- The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
The secondary hypotheses are:
- The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
- The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
- Conditions
- Breastfeeding
- Being tested
- In-hospital professional support, Postpartum telephone follow-up support
- Keywords
- Breastfeeding, professional support, postnatal, interventions, exclusive breastfeeding, randomized controlled trial
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-hospital professional supportOther
In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
Postpartum telephone follow-up supportOther
Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team. |
| In-hospital professional support | Experimental | The participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization. Receives: Other: In-hospital professional support |
| Postpartum telephone follow-up support | Experimental | Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum. Receives: Other: Postpartum telephone follow-up support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
Measured: 1 month postpartum
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
Measured: 2 months postpartum
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
Measured: 3 months postpartum
Secondary outcomes (1)
Median duration of breastfeeding
The median duration of any breastfeeding and the median duration of exclusive breastfeeding.
Measured: 6 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Tarrant, The University of Hong Kong
- Investigators
- Marie Tarrant, PhD, MPH, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893736
- Sponsor's protocol ID
- PBFS-1
- Status last verified
- Mar 2015
- First submitted
- 6 Jun 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fu IC, Fong DY, Heys M, Lee IL, Sham A, Tarrant M. Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. BJOG. 2014 Dec;121(13):1673-83. doi: 10.1111/1471-0528.12884. Epub 2014 May 26.
PubMed 24861802
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
- ClinicalTrials.gov ID
- NCT01893736
- Acronym / sponsor ID
- PBFS-1
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, professional support, postnatal, interventions, exclusive breastfeeding, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Jul 2013 (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.
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
Detailed description
The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.
The primary hypotheses are:
- Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
- The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
The secondary hypotheses are:
- The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
- The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team. |
| In-hospital professional support | Experimental | Other: In-hospital professional supportThe participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization. |
| Postpartum telephone follow-up support | Experimental | Other: Postpartum telephone follow-up supportParticipants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- delivers at participating trial site,
- primiparous,
- intends to breastfeed,
- 18 years of age or older,
- has singleton pregnancy,
Key exclusion criteria (7 listed)
- < 37 weeks gestation,
- an Apgar score < 8 at five minutes,
- a birth weight < 2500 grams,
- born with any severe medical conditions or congenital malformations,
- is placed in the special care nursery for more than 48 hours after delivery,
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 |
|---|---|---|
| In-hospital professional supportIn-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk. | Other | In-hospital professional support |
| Postpartum telephone follow-up supportPostpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk. | Other | Postpartum telephone follow-up support |
Primary outcome
Prevalence of any and exclusive breastfeeding
Time frame: 1 month postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
Prevalence of any and exclusive breastfeeding
Time frame: 2 months postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
Prevalence of any and exclusive breastfeeding
Time frame: 3 months postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
1 secondary outcome
Median duration of breastfeeding
Time frame: 6 month postpartum
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 17 Mar 2015.
- Results publication: PubMed 24861802Fu IC, Fong DY, Heys M, Lee IL, Sham A, Tarrant M. Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. BJOG. 2014 Dec;121(13):1673-83. doi: 10.1111/1471-0528.12884. Epub 2014 May 26.
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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.
Marie Tarrant, PhD, MPH, RN principal investigator
The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-hospital professional support and Postpartum telephone follow-up support in people with Breastfeeding, run by The University of Hong Kong at 4 sites in Hong Kong.
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 8 inclusion and 7 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. 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?
Prevalence of any and exclusive breastfeeding (time frame: 1 month postpartum). The study lists 3 primary outcomes in all. 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 NCT01893736, which also lists 1 linked publication.
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 17 Mar 2015.