Effect of Peppermint Water on Breast Crack

Breast Diseases Clinical Trial

Official title:

Effect of Peppermint Water on Prevention of Nipple Crack in Lactating Primiparous Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456404
• Other study ID #: 85-2
• Status: Completed
• Phase: N/A
• First received: April 4, 2007
• Last updated: April 4, 2007
• Start date: February 2005
• Est. completion date: June 2005

Study information

• Verified date: March 2004
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Drug:
• peppermint water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome that the study was designed to evaluate: the presence and severity of sore nipples, nipple pain.
Primary	The time at which the outcome is measured: nipple and areola cracks, and pain at days 4, 8, 14.
Secondary	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