BreastfeedingPhase 3NCT00270192
Antenatal Educational Intervention for Improvement of Breastfeeding
A Phase 3 study testing individual lactation counseling and educational material, educational material alone and routine antenatal care without educational intervention in people with Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- individual lactation counseling and educational material, educational material alone and routine antenatal care without educational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteSingapore
- Study dates
- May 2002to Dec 2004
- Phase
- Phase 3
- 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 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- gestation of at least 36 weeks at recruitment
- no uterine scar
- the absence of any obstetric complication that would contraindicate vaginal delivery.
Who cannot join
- refusal to participate in trial
- contraindications to labour, vaginal delivery, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects Of Antenatal Breast Preparation On The Successful Initiation And Continuation Of Breastfeeding In Singaporean Mothers
This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting.
Hypothesis: A single antenatal encounter, which includes breastfeeding educational material and individual instruction with a lactation counselor, can improve the initiation, duration and exclusivity of breastfeeding compared to routine antenatal care or the use of educational material alone
Read the detailed description
Breastfeeding rates in many developed countries, particularly in terms of exclusive and predominant breastfeeding, often fall short of the recommended practice advised by the World Health Organization and the American Academy of Pediatrics. Despite increasing awareness of the many advantages of breastfeeding the challenge remains to implement programs that can effectively improve short and long-term breastfeeding rates.
The Singapore National Breastfeeding Survey 2001 (Foo et al, 2005) demonstrated an encouraging breastfeeding initiation rate of 94.5%. However only 21.1% continued to breastfeed at 6 months with fewer than 5% breastfeeding exclusively.
The formal preparation of expectant mothers for breastfeeding is not part of routine antenatal care in many practices. We feel that it may prove beneficial especially in an environment with a low prevalence of breastfeeding. The aim of this trial is to demonstrate the impact of single-encounter antenatal education combining educational material with individual instruction, on breastfeeding initiation and duration and on infant feeding practice, compared with routine antenatal care and educational material alone in a tertiary hospital setting.
401 women are randomized into 3 predetermined groups and are exposed to specific antenatal education materials targeting breastfeeding techniques; the control group receives routine antenatal care. Data regarding breastfeeding rate, quality and duration is collected over a 1 year period.
Comparisons: breastfeeding initiation rate, duration and type among women receiving lactation counseling with educational material, educational material without individual counseling, and routine antenatal care without educational intervention
- Conditions
- Breastfeeding
- Being tested
- individual lactation counseling and educational material, educational material alone, routine antenatal care without educational intervention
- Keywords
- Breastfeeding, exclusive, education, counseling
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual lactation counseling and educational materialBehavioural
educational material aloneBehavioural
routine antenatal care without educational interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of exclusive or predominant breastfeeding rates in intervention groups versus controls
Secondary outcomes (1)
Breastfeeding initiation, defined as any breastfeeding type within the first 2 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startMay 2002
- Study completionDec 2004
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 National University Hospital, SingaporeThe 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 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Yah Shih Chan, MHSc, Principal investigator, National University Hospital, SingaporeCitra N Mattar, MRANZCOG, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270192
- Sponsor's protocol ID
- NHG RPR 01101
- Status last verified
- Dec 2005
- First submitted
- 23 Dec 2005
- Last updated
- 24 Oct 2006
- Results posted
- No
Publications
Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.
PubMed 15814526
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Antenatal Breast Preparation On The Successful Initiation And Continuation Of Breastfeeding In Singaporean Mothers
- ClinicalTrials.gov ID
- NCT00270192
- Acronym / sponsor ID
- NHG RPR 01101
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, exclusive, education, counseling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Dec 2004
- First posted
- 26 Dec 2005 (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.
This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting.
Hypothesis: A single antenatal encounter, which includes breastfeeding educational material and individual instruction with a lactation counselor, can improve the initiation, duration and exclusivity of breastfeeding compared to routine antenatal care or the use of educational material alone
Detailed description
Breastfeeding rates in many developed countries, particularly in terms of exclusive and predominant breastfeeding, often fall short of the recommended practice advised by the World Health Organization and the American Academy of Pediatrics. Despite increasing awareness of the many advantages of breastfeeding the challenge remains to implement programs that can effectively improve short and long-term breastfeeding rates.
The Singapore National Breastfeeding Survey 2001 (Foo et al, 2005) demonstrated an encouraging breastfeeding initiation rate of 94.5%. However only 21.1% continued to breastfeed at 6 months with fewer than 5% breastfeeding exclusively.
The formal preparation of expectant mothers for breastfeeding is not part of routine antenatal care in many practices. We feel that it may prove beneficial especially in an environment with a low prevalence of breastfeeding. The aim of this trial is to demonstrate the impact of single-encounter antenatal education combining educational material with individual instruction, on breastfeeding initiation and duration and on infant feeding practice, compared with routine antenatal care and educational material alone in a tertiary hospital setting.
401 women are randomized into 3 predetermined groups and are exposed to specific antenatal education materials targeting breastfeeding techniques; the control group receives routine antenatal care. Data regarding breastfeeding rate, quality and duration is collected over a 1 year period.
Comparisons: breastfeeding initiation rate, duration and type among women receiving lactation counseling with educational material, educational material without individual counseling, and routine antenatal care without educational intervention
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- gestation of at least 36 weeks at recruitment
- no uterine scar
- the absence of any obstetric complication that would contraindicate vaginal delivery.
Key exclusion criteria (2 listed)
- refusal to participate in trial
- contraindications to labour, vaginal delivery, breastfeeding
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 |
|---|---|---|
| individual lactation counseling and educational material | Behavioural | – |
| educational material alone | Behavioural | – |
| routine antenatal care without educational intervention | Behavioural | – |
Primary outcome
Comparison of exclusive or predominant breastfeeding rates in intervention groups versus controls
1 secondary outcome
Breastfeeding initiation, defined as any breastfeeding type within the first 2 weeks of delivery
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 24 Oct 2006.
- Background: PubMed 15814526Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.
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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.
Yah Shih Chan, MHSc principal investigator
National University Hospital, Singapore
Citra N Mattar, MRANZCOG principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing individual lactation counseling and educational material, educational material alone and routine antenatal care without educational intervention in people with Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
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 4 inclusion and 2 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 24 Oct 2006. 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 Singapore. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of exclusive or predominant breastfeeding rates in intervention groups versus controls. 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 NCT00270192, 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 24 Oct 2006.