PainPhase 4LanPNCT01420419
Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
A Phase 4 study testing Lanolin and Standard (usual) in-hospital and community postpartum care in people with Pain, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Lanolin and Standard (usual) in-hospital and community postpartum care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Mar 2012
- Phase
- Phase 4
- 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
- Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
- Infant delivered at, or greater than 37 weeks gestation.
- Singleton birth.
- Speaks and understands English.
- Access to telephone.
Who cannot join
- Infant not expected to be discharged home with mother.
- Infant with congenital abnormalities that would impair breastfeeding.
- Maternal allergy to lanolin.
- Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Postpartum Unit St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.
- Conditions
- Pain
- Being tested
- Lanolin, Standard (usual) in-hospital and community postpartum care
- Keywords
- nipple pain, breastfeeding, nipple damage, lanolin, clinical trial
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanolinOther
Pea-sized amount of lanolin applied to each nipple after every breastfeeding session (approximately 8-12 times daily) until complete resolution of nipple pain and damage for a maximum of 7 days.
Standard (usual) in-hospital and community postpartum careOther
Women randomized to standard care will not receive lanolin or information regarding how to use lanolin. In-hospital standard care may include any of the following pain management measures at the recommendation / discretion of the participant's health care provider, or based on the patient's personal preference: analgesics (such as ibuprofen or acetaminophen); application of cold or warm compresses; application of ice packs; use of breast shields; air drying the nipples; or applying expressed breast milk.
| Study group | Role | What they receive |
|---|---|---|
| Lanolin | Experimental | Pea sized amount of lanolin to be applied to nipple and areola after every breast feed (approximately every 2-3 hours), until pain is completely resolved for a maximum of 7 days Receives: Other: Lanolin |
| Standard postpartum nursing care | Other | Women in standard care control group may receive any other nursing intervention to manage their nipple pain, including (but not limited to): recommending application of expressed breast milk, analgesics (such as acetaminophen or ibuprofen), breast shells, air drying, changing position / latch, cold or warm compresses Receives: Other: Standard (usual) in-hospital and community postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple pain severity
Measured with a 10-point numeric rating scale (NRS)
Measured: 4 days post randomization
Secondary outcomes (2)
Breastfeeding duration
Measured by asking women the last time their infant was breastfed. Breastfeeding duration will be calculated as the difference between the infant's date of birth, and the last day (date) the infant was breastfed.
Measured: 4 and 12 weeks postpartum
Breastfeeding exclusivity
Measured with Labbok \& Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)
Measured: 4 and 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy-Lee Dennis, University of Toronto
- Investigators
- Cindy-Lee Dennis, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420419
- Sponsor's protocol ID
- 26044
- Acronym
- LanP
- Status last verified
- Jan 2013
- First submitted
- 29 Mar 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
- ClinicalTrials.gov ID
- NCT01420419
- Acronym / sponsor ID
- LanP / 26044
- Conditions
- Pain
- Keywords
- nipple pain, breastfeeding, nipple damage, lanolin, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Aug 2011 (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 purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanolin | Experimental | Other: LanolinPea sized amount of lanolin to be applied to nipple and areola after every breast feed (approximately every 2-3 hours), until pain is completely resolved for a maximum of 7 days |
| Standard postpartum nursing care | Other | Other: Standard (usual) in-hospital and community postpartum careWomen in standard care control group may receive any other nursing intervention to manage their nipple pain, including (but not limited to): recommending application of expressed breast milk, analgesics (such as acetaminophen or ibuprofen), breast shells, air drying, changing position / latch, cold or warm compresses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
- Infant delivered at, or greater than 37 weeks gestation.
- Singleton birth.
- Speaks and understands English.
- Access to telephone.
Key exclusion criteria (4 listed)
- Infant not expected to be discharged home with mother.
- Infant with congenital abnormalities that would impair breastfeeding.
- Maternal allergy to lanolin.
- Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.
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 |
|---|---|---|
| LanolinPea-sized amount of lanolin applied to each nipple after every breastfeeding session (approximately 8-12 times daily) until complete resolution of nipple pain and damage for a maximum of 7 days. | Other | Lanolin |
| Standard (usual) in-hospital and community postpartum careWomen randomized to standard care will not receive lanolin or information regarding how to use lanolin. In-hospital standard care may include any of the following pain management measures at the recommendation / discretion of the participant's health care provider, or based on the patient's personal preference: analgesics (such as ibuprofen or acetaminophen); application of cold or warm compresses; application of ice packs; use of breast shields; air drying the nipples; or applying expressed breast milk. | Other | Standard postpartum nursing care |
Primary outcome
Nipple pain severity
Time frame: 4 days post randomization
Measured with a 10-point numeric rating scale (NRS)
2 secondary outcomes
Breastfeeding duration
Time frame: 4 and 12 weeks postpartum
Breastfeeding exclusivity
Time frame: 4 and 12 weeks 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 16 Jan 2013.
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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.
Cindy-Lee Dennis, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanolin and Standard (usual) in-hospital and community postpartum care in people with Pain, run by University of Toronto 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 5 inclusion and 4 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 16 Jan 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Nipple pain severity (time frame: 4 days post randomization). 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 16 Jan 2013.