The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack (NCT04259320) | Clinical Trial Compass
CompletedNot Applicable
The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
Turkey (Türkiye)90 participantsStarted 2020-02-17
Plain-language summary
In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing barrier and breast milk used in the first ten days of breastfeeding to prevent the formation of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women. Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no treatment-control).
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being over 18 years old;
* Normal spontaneous delivery.
* Pregnancy weeks between 37-42.
* Single birth.
* Initiated breastfeeding.
* Having given birth to a healthy, full-term child.
* Newborn with no oral, palatal or maxillofacial abnormalities.
* Not taking any medication, considering that drug use may cause nipple problems.
* Being able to read and write.
* Volunteering to participate in the study.
* Not having contraindications for breastfeeding.
Exclusion Criteria:
* Not approving to participate in the research.
* Being a multipara.
* Not breastfeeding within the first 24 hours.
* Development of any breast problem: Mastitis, engorgement etc.
* Taking newborn into intensive care.
* Not sticking to the application.
* Using another nipple crack preventing method during application.
* Being allergic to beeswax.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Nipple crack change
Timeframe: Change from baseline nipple crack at 10 days