Nipple Pain During LactationBESTNCT01092156
Prenatal Breastfeeding Education to Reduce Nipple Pain
A study testing Education in people with Nipple Pain During Lactation, run by University of California, Davis at 1 site in United States.
Trial summary
This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch. 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
- Nipple Pain During Lactation
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2008
- 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
- Pregnant women who intend to breastfeed their infants
- Single infant
- Resides in catchment area
- Has phone
- Speaks English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.
- Conditions
- Nipple Pain During Lactation
- Being tested
- Education
- Keywords
- Nipple pain during lactation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education on Infant-led latching
| Study group | Role | What they receive |
|---|---|---|
| Education on Infant-led latching | Active comparator | Not described Receives: Behavioral: Education |
| Standard education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple pain day 3 postpartum
Measured: Day 3 postpartum
Secondary outcomes (1)
Breastfeeding status day 30 postpartum
Measured: Day 30 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple Pain During LactationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Association of American Medical Colleges, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Caroline J Chantry, M.D., Principal investigator, University of California, DavisKathryn G Dewey, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092156
- Sponsor's protocol ID
- 200614137-5
- Other IDs
- MM-0844-05/05
- Acronym
- BEST
- Status last verified
- Sep 2023
- First submitted
- 22 Mar 2010
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Breastfeeding Education to Reduce Nipple Pain
- ClinicalTrials.gov ID
- NCT01092156
- Acronym / sponsor ID
- BEST / 200614137-5
- Conditions
- Nipple Pain During Lactation
- Keywords
- Nipple pain during lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Association of American Medical Colleges, Centers for Disease Control and Prevention
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Mar 2010 (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 study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education on Infant-led latching | Active comparator | Behavioral: Education |
| Standard education | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women who intend to breastfeed their infants
- Single infant
- Resides in catchment area
- Has phone
- Speaks English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EducationEducation on Infant-led latching | Behavioural | Education on Infant-led latching |
Primary outcome
Nipple pain day 3 postpartum
Time frame: Day 3 postpartum
1 secondary outcome
Breastfeeding status day 30 postpartum
Time frame: Day 30 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 28 Sep 2023.
Related trials for Nipple Pain During Lactation
Not yet recruiting
The Effect of Nursing Pillow Use on Nipple Pain and Comfort
Nipple Pain During Lactation, Comfort
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.
Caroline J Chantry, M.D. principal investigator
University of California, Davis
Kathryn G Dewey, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Nipple Pain During Lactation, run by University of California, Davis at 1 site in United States.
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 5 inclusion and 0 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 28 Sep 2023. 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 United States. 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?
Nipple pain day 3 postpartum (time frame: Day 3 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.