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Effect of Peppermint Water on Breast Crack

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00456404
First received: April 4, 2007
Last updated: NA
Last verified: March 2004
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tabriz University:

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

Estimated Enrollment: 196
Study Start Date: February 2005
Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456404

Sponsors and Collaborators
Tabriz University
Investigators
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 May 19, 2013