BreastfeedingABFSNCT01648114
A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
A study testing Antenatal Breastfeeding Intervention in people with Breastfeeding and Pregnancy, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial summary
The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding. 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, Pregnancy
- What is being tested?
- Antenatal Breastfeeding Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 3 sitesHong Kong
- Study dates
- Aug 2012to Feb 2014
- 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
- singleton pregnancy,
- primiparous
- 18 years of age or older,
- at least 36 weeks of gestation,
- Cantonese speaking,
- Hong Kong resident,
Show all 9Show fewer
- no serious medical or obstetrical complications,
- staying in Hong Kong for at least 6 months after delivery, and
- intention to breastfeed.
Who cannot join
- Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Kwong Wah Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tsan Yuk Hospital
Hong Kong
About this study
The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.
Read the detailed description
The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding.
- Conditions
- Breastfeeding, Pregnancy
- Being tested
- Antenatal Breastfeeding Intervention
- Keywords
- breastfeeding, pregnancy, antenatal, exclusive breastfeeding, education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal Breastfeeding InterventionOther
The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy. |
| Antenatal Breastfeeding Intervention | Experimental | Antenatal intervention group will receive usual care plus a 20 to 30-minute one-to-one educational intervention about breastfeeding. Receives: Other: Antenatal Breastfeeding Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Breastfeeding Rate
Exclusive breastfeeding rate at 6 weeks postpartum
Measured: 6 weeks postpartum
Secondary outcomes (2)
Median Duration of Breastfeeding
The median duration of exclusive breastfeeding and the median duration of any breastfeeding
Measured: 6 months postpartum
Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum
Rate of Exclusive Breastfeeding at 3 Months and 6 Months Postpartum
Measured: 6 Months Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionFeb 2014
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
- 472 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
- NCT01648114
- Sponsor's protocol ID
- ABFS-1
- Acronym
- ABFS
- Status last verified
- Mar 2015
- First submitted
- 18 Jul 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong KL, Tak Fong DY, Yin Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-968. doi: 10.1097/AOG.0000000000000481.
PubMed 25437725
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 an Antenatal Intervention to Increase Exclusive Breastfeeding
- ClinicalTrials.gov ID
- NCT01648114
- Acronym / sponsor ID
- ABFS / ABFS-1
- Conditions
- Breastfeeding, Pregnancy
- Keywords
- breastfeeding, pregnancy, antenatal, exclusive breastfeeding, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Jul 2012 (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 educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.
Detailed description
The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy. |
| Antenatal Breastfeeding Intervention | Experimental | Other: Antenatal Breastfeeding InterventionAntenatal intervention group will receive usual care plus a 20 to 30-minute one-to-one educational intervention about breastfeeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- singleton pregnancy,
- primiparous
- 18 years of age or older,
- at least 36 weeks of gestation,
- Cantonese speaking,
Key exclusion criteria (1 listed)
- Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).
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 |
|---|---|---|
| Antenatal Breastfeeding InterventionThe intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding | Other | Antenatal Breastfeeding Intervention |
Primary outcome
Exclusive Breastfeeding Rate
Time frame: 6 weeks postpartum
Exclusive breastfeeding rate at 6 weeks postpartum
2 secondary outcomes
Median Duration of Breastfeeding
Time frame: 6 months postpartum
Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum
Time frame: 6 Months 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 25437725Wong KL, Tak Fong DY, Yin Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-968. doi: 10.1097/AOG.0000000000000481.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal Breastfeeding Intervention in people with Breastfeeding and Pregnancy, run by The University of Hong Kong at 3 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 9 inclusion and 1 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 3 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?
Exclusive Breastfeeding Rate (time frame: 6 weeks postpartum). 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 NCT01648114, 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.