Effect of Peppermint Water on Breast Crack
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Diseases |
Drug: peppermint water |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Peppermint Water on Prevention of Nipple Crack in Lactating Primiparous Women: a Randomized Controlled Trial |
- 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.
- 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
| Estimated Enrollment: | 196 |
| Study Start Date: | February 2005 |
| Study Completion Date: | June 2005 |
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.
Eligibility| Ages Eligible for Study: | 14 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00456404
| Study Director: | Manizheh Sayyah Melli, MD | Tabriz University of Medical Sciences |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00456404 History of Changes |
| Other Study ID Numbers: | 85-2 |
| Study First Received: | April 4, 2007 |
| Last Updated: | April 4, 2007 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Tabriz University:
|
peppermint water nipple crack lactating women |
Additional relevant MeSH terms:
|
Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on February 25, 2015