Clinical trial NCT04259320: The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
Official title: Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Cracked Nipple in Puerperium
Lead sponsor: Karabuk University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Karabuk Training and Research Hospital
First posted: 2020-02-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

Brief 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).

Detailed description: Current evidence-based guidelines report that the incidence of nipple cracks ranges between 34-96%. Nipple cracks generally occur in the first week after the birth and may continue in the following periods of breastfeeding. Nipple crack is the second most common reason to stop breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies has been expressed as extremely painful and terrible. It is known that breast milk, olive oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks, will successfully allow to continue breastfeeding. In this way, breastfeeding will not be interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months. Using non-pharmacological, effective and therapeutic methods will also have a positive effect to increase the rate of breastfeeding.

Studies in the literature cover the evaluation of the effectiveness of beeswax or beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an effective and sufficient material in preventing and healing nipple cracks.

In this study, it is planned to include 90 lactating women (30 women in each group) to meet the parametric test assumptions in the experimental and control groups (beeswax-containing barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the experimental and control groups will be randomized.

Eligibility criteria: 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.

Primary outcomes:
measure: Nipple crack change
timeFrame: Change from baseline nipple crack at 10 days
Secondary outcomes:
measure: Severity of nipple pain change
timeFrame: Change from baseline severity of nipple pain at 10 days.
Other outcomes:
measure: Presence of nipple pain change
timeFrame: Change from baseline presence of nipple pain at 10 days.
measure: Maternal satisfaction
timeFrame: Baseline from baseline nipple crack at 10 days
Locations:
city: Karabük
country: Turkey
facility: Karabuk University Training and Research Hospital
state: Merkez
Study officials:
affiliation: Karabuk University Research and Training Hospital
name: Sibel Mutlu, OB/GYN
role: STUDY_DIRECTOR
References:
citation: Buck ML, Amir LH, Cullinane M, Donath SM; CASTLE Study Team. Nipple pain, damage, and vasospasm in the first 8 weeks postpartum. Breastfeed Med. 2014 Mar;9(2):56-62. doi: 10.1089/bfm.2013.0106. Epub 2013 Dec 31.
citation: Puapornpong P, Paritakul P, Suksamarnwong M, Srisuwan S, Ketsuwan S. Nipple Pain Incidence, the Predisposing Factors, the Recovery Period After Care Management, and the Exclusive Breastfeeding Outcome. Breastfeed Med. 2017 Apr;12:169-173. doi: 10.1089/bfm.2016.0194. Epub 2017 Mar 9.
citation: Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2.