Cracked Nipple During LactationNCT03568370
Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
A study testing olive oil in people with Cracked Nipple During Lactation, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. 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
- Cracked Nipple During Lactation
- What is being tested?
- olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Oct 2017to Sep 2018
- 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
- Normal spontaneous delivery.
- Pregnancy weeks between 37-42.
- Single birth.
- Initiated breastfeeding.
Who cannot join
- Presence of crack in the nipple.
- Medication applied to the nipple
- The maternal health condition that may interfere with breastfeeding.
- The infant with congenital abnormalities that would impair breastfeeding.
- The infant attained low birth weight or other criteria to intensive care unit.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Lin
Taipei, Neihu, 114
Chen-Xi Lin, 917112589, lin050027@hotmail.com
About this study
The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.
Read the detailed description
Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.
- Conditions
- Cracked Nipple During Lactation
- Being tested
- olive oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oilOther
Also called human milk
Evaluate the effectiveness of olive oil and human milk in the prevention of nipple cracking, nipple pain and maternal satisfaction in lactating women during the first 3 days of treatment and the 7th and 10th day after delivery.
| Study group | Role | What they receive |
|---|---|---|
| olive oil | Experimental | use one drop olive oil on each nipple after each feeding Receives: Other: olive oil |
| breast milk | No intervention | use breast milk on each nipple after each feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple pain change
use Numeric Rating Scale 0-10 point
Measured: Change from baseline nipple pain at 10 days
Nipple sore change
use Nipple Soreness Score 0-5 point
Measured: Change from baseline nipple pain at 10 days
Nipple trauma change
use Nipple Trauma Score 0-5 point
Measured: Change from baseline nipple trauma at 10 days
breastfeeding duration
use Infant Feeding Categories
Measured: 30 days
Secondary outcomes (1)
Maternal satisfaction
use Maternal Satisfaction Questionnaire 0-40 point
Measured: baseline from Baseline nipple sore at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start13 Oct 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
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 Cracked Nipple During LactationStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin, Chen-xi, National Defense Medical Center, Taiwan
- Investigators
- Chen-Xi Lin, Study chair, lin050027@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568370
- Sponsor's protocol ID
- 1-106-05-131
- Status last verified
- Jun 2018
- First submitted
- 11 Oct 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lin CX, Lu YY. Comparative Effectiveness of Olive Oil and Breast Milk on Nipple Soreness in Breastfeeding Mothers. Breastfeed Med. 2023 Oct;18(10):779-784. doi: 10.1089/bfm.2023.0081. Epub 2023 Oct 5.
PubMed 37797219
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
- ClinicalTrials.gov ID
- NCT03568370
- Acronym / sponsor ID
- 1-106-05-131
- Conditions
- Cracked Nipple During Lactation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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 aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.
Detailed description
Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olive oil | Experimental | Other: olive oiluse one drop olive oil on each nipple after each feeding |
| breast milk | No intervention | –use breast milk on each nipple after each feeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal spontaneous delivery.
- Pregnancy weeks between 37-42.
- Single birth.
- Initiated breastfeeding.
Key exclusion criteria (5 listed)
- Presence of crack in the nipple.
- Medication applied to the nipple
- The maternal health condition that may interfere with breastfeeding.
- The infant with congenital abnormalities that would impair breastfeeding.
- The infant attained low birth weight or other criteria to intensive care unit.
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 |
|---|---|---|
| olive oilAlso: human milkEvaluate the effectiveness of olive oil and human milk in the prevention of nipple cracking, nipple pain and maternal satisfaction in lactating women during the first 3 days of treatment and the 7th and 10th day after delivery. | Other | olive oil |
Primary outcome
Nipple pain change
Time frame: Change from baseline nipple pain at 10 days
use Numeric Rating Scale 0-10 point
Nipple sore change
Time frame: Change from baseline nipple pain at 10 days
use Nipple Soreness Score 0-5 point
Nipple trauma change
Time frame: Change from baseline nipple trauma at 10 days
use Nipple Trauma Score 0-5 point
breastfeeding duration
Time frame: 30 days
use Infant Feeding Categories
1 secondary outcome
Maternal satisfaction
Time frame: baseline from Baseline nipple sore at 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 37797219Lin CX, Lu YY. Comparative Effectiveness of Olive Oil and Breast Milk on Nipple Soreness in Breastfeeding Mothers. Breastfeed Med. 2023 Oct;18(10):779-784. doi: 10.1089/bfm.2023.0081. Epub 2023 Oct 5.
- Individual participant dataSharing planned: Undecided
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.
Chen-Xi Lin study chair
lin050027@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olive oil in people with Cracked Nipple During Lactation, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Xi Lin (917112589, lin050027@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple pain change (time frame: Change from baseline nipple pain at 10 days). The study lists 4 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 NCT03568370, 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 26 Jun 2018.