Effect of Peppermint Water on Breast Crack
1 other identifier
interventional
196
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2005
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 4, 2007
CompletedFirst Posted
Study publicly available on registry
April 5, 2007
CompletedApril 5, 2007
March 1, 2004
April 4, 2007
April 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manizheh Sayyah Melli, MD
Tabriz University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 4, 2007
First Posted
April 5, 2007
Study Start
February 1, 2005
Study Completion
June 1, 2005
Last Updated
April 5, 2007
Record last verified: 2004-03