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 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:

MedlinePlus related topics: Breast Diseases Drinking Water

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 (Child, Adult)
Sexes 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

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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


ClinicalTrials.gov Identifier:	NCT00456404 History of Changes
Other Study ID Numbers:	85-2
Study First Received:	April 4, 2007
Last Updated:	April 4, 2007

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 25, 2017

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