Clinical trial NCT04153513: Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women
Official title: Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breastfeeding
Lead sponsor: University of Mostar
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
First posted: 2019-11-06
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Participants will be allocated in two groups and will receive education prior to the study.

Detailed description: Recent studies show that early termination of breastfeeding is often associated with painful and sore nipples. Although health professionals recommend various treatments for painful and sore nipples, including alternative treatments, there is currently not enough evidence to recommend specific treatment of painful and sore nipples in lactating women. The primary objective of this study is to compare the effect of lanolin administration and the application of breast milk on the intensity of pain and healing of damaged nipples during breastfeeding. Subjects in the lanolin group will apply lanolin on each nipple and areola after each feeding while subjects in the breast milk group will apply several drops of milk on the nipple after each feed and allow them to air dry. In both groups, the treatment will last for 7 days or until the symptoms of pain and nipple damage have ceased. The main outcome measure is pain, which will be assessed through three time points and will be measured using an abridged version of the McGill Pain Questionnaire. Nipple damage will be assessed by means of a validated assessment tool, the Nipple trauma score. Secondary outcome measures will include breastfeeding efficacy, duration of any/exclusive breastfeeding, reasons for stopping breastfeeding and satisfaction with proposed treatment.The contribution of this study will be reflected in efficient treatment, better care of health professional in the prevention and treatment of damaged and sore nipples, and the study will also contribute in defining the guidelines for the development of procedure in midwifery practice for the treatment of painful and damaged nipples.

Eligibility criteria: Inclusion Criteria:

* Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
* Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
* Access to telephone
* Signed Informed consent

Exclusion Criteria:

* Primiparas with mental disorders
* Mothers allergy to lanolin
* Mothers with abnormal nipples
* Breast hypoplasia
* Infant with cleft palate
* Ankyloglossia
* Unsigned Informed consent

Primary outcomes:
measure: Change in nipple pain severity
timeFrame: baseline, 3 and 7 days post randomization
measure: Nipple damage change
timeFrame: baseline, 3 and 7 days post randomization
Secondary outcomes:
measure: Assessment of breastfeeding self-efficacy
timeFrame: baseline, 3 and 7 days post randomization
measure: Breastfeeding duration and exclusivity.
timeFrame: 3 and 7 days post randomization, 3 and 6 months postpartum
measure: Satisfaction with proposed treatment
timeFrame: 3 and 6 months postpartum
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
state: HNŽ
Study officials:
affiliation: Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
name: Olivera Perić, VII
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Hospital Centre Zagreb
name: Anita Pavičić Bošnjak, VII
role: STUDY_CHAIR
affiliation: Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
name: Vajdana Tomić, VII
role: STUDY_CHAIR
References:
citation: Pavicic Bosnjak A, Rumboldt M, Stanojevic M, Dennis CL. Psychometric assessment of the croatian version of the breastfeeding self-efficacy scale-short form. J Hum Lact. 2012 Nov;28(4):565-9. doi: 10.1177/0890334412456240. Epub 2012 Sep 6.
citation: Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.
citation: Peric O, Pavicic Bosnjak A, Mabic M, Tomic V. Comparison of Lanolin and Human Milk Treatment of Painful and Damaged Nipples: A Randomized Control Trial. J Hum Lact. 2023 May;39(2):236-244. doi: 10.1177/08903344221135793. Epub 2022 Nov 18.