Back to resultsEffect of Peppermint Water on Breast Crack
Primary Purpose
Breast Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peppermint water
Sponsored by
About this trial
This is an interventional prevention trial for Breast Diseases focused on measuring peppermint water, nipple crack, lactating women
Eligibility Criteria
Inclusion Criteria:
- New mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. The sample of breastfeeding mothers were collected in two cohorts according delivery type. Each group consisted of 98 primipara mothers.
Exclusion Criteria:
- Mothers who didn't plan to use peppermint water
- Discharged before an interview or had preterm delivery
- Postpartum fever
- Breast infection
- Nipple abnormalities
- Age less than 18 years
- Twins
- Taking medications at night
- Mothers who didn't have telephone line, and who were illiterate.
- Infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary outcome that the study was designed to evaluate: the presence and severity of sore nipples, nipple pain.
The time at which the outcome is measured: nipple and areola cracks, and pain at days 4, 8, 14.
Secondary Outcome Measures
The frequency and duration of breastfeeding at days 4, 8, 14 and the number of mothers who continued feeding at week 6 was used as the secondary outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456404
Brief Title
Effect of Peppermint Water on Breast Crack
Official Title
Effect of Peppermint Water on Prevention of Nipple Crack in Lactating Primiparous Women: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effectiveness of a topical preparation of peppermint water in comparison with that of expressed breast milk for the prevention of nipple cracks in primiparous breastfeeding women.
Detailed Description
One hundred and ninety-six primipara participants, who are breastfeeding after delivery at 38 or more week gestation, were assigned randomly to 2 groups, with one of 2 regimens (peppermint water, an old household remedy, and no treatment only using breast milk) to right and left sides. Each group was followed for a maximum of 3 visits within 14 days and until the 6 weeks postpartum by telephone call. The aerial parts of Mentha piperita were purchased from Hakim Momen Tabrizi Company, and the identity was confirmed by morphological characterization in comparison with the herbarium specimen retained in the School of Pharmacy, Tabriz University of Medical Sciences. Also, a voucher specimen has been generated in that herbarium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
peppermint water, nipple crack, lactating women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
peppermint water
Primary Outcome Measure Information:
Title
The primary outcome that the study was designed to evaluate: the presence and severity of sore nipples, nipple pain.
Title
The time at which the outcome is measured: nipple and areola cracks, and pain at days 4, 8, 14.
Secondary Outcome Measure Information:
Title
The frequency and duration of breastfeeding at days 4, 8, 14 and the number of mothers who continued feeding at week 6 was used as the secondary outcome
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
New mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. The sample of breastfeeding mothers were collected in two cohorts according delivery type. Each group consisted of 98 primipara mothers.
Exclusion Criteria:
Mothers who didn't plan to use peppermint water
Discharged before an interview or had preterm delivery
Postpartum fever
Breast infection
Nipple abnormalities
Age less than 18 years
Twins
Taking medications at night
Mothers who didn't have telephone line, and who were illiterate.
Infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manizheh Sayyah Melli, MD
Organizational Affiliation
Tabriz University of Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of Peppermint Water on Breast Crack
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