Effect of Peppermint Water on Breast Crack

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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peppermint water

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Manizheh Sayyah Melli, MD

Role: STUDY_DIRECTOR

Tabriz University of Medical Sciences

Other Identifiers

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85-2

Identifier Type: -

Identifier Source: org_study_id