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Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women

NCT04153513 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-02-16

No results posted yet for this study

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.

Conditions

  • Breastfeeding

Interventions

DRUG

Lanolin

Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

OTHER

Mother's milk

After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    collaborator OTHER

  • University of Mostar

    lead OTHER

Principal Investigators

  • Olivera Perić, VII · Department of Gynecology and Obstetrics, University Clinical Hospital Mostar

  • Anita Pavičić Bošnjak, VII · Clinical Hospital Centre Zagreb

  • Vajdana Tomić, VII · Department of Gynecology and Obstetrics, University Clinical Hospital Mostar

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153513 on ClinicalTrials.gov