Effect of Peppermint Water on Breast Crack
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ClinicalTrials.gov Identifier: NCT00456404 |
Recruitment Status
:
Completed
First Posted
: April 5, 2007
Last Update Posted
: April 5, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Diseases | Drug: peppermint water | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 196 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Effect of Peppermint Water on Prevention of Nipple Crack in Lactating Primiparous Women: a Randomized Controlled Trial |
Study Start Date : | February 2005 |
Actual Study Completion Date : | June 2005 |
- 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

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Ages Eligible for Study: | 14 Years to 40 Years (Child, Adult) |
Sexes 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456404
Study Director: | Manizheh Sayyah Melli, MD | Tabriz University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00456404 History of Changes |
Other Study ID Numbers: |
85-2 |
First Posted: | April 5, 2007 Key Record Dates |
Last Update Posted: | April 5, 2007 |
Last Verified: | March 2004 |
Keywords provided by Tabriz University:
peppermint water nipple crack lactating women |
Additional relevant MeSH terms:
Breast Diseases Skin Diseases |