Completed

Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+18

+ Pathologic Complete Response

+ Bacterial Infections and Mycoses

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2006
See protocol details

Summary

Principal SponsorState University of New York - Upstate Medical University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2006

Actual date on which the first participant was enrolled.

Lactation mastitis is an acute inflammation of the interlobular connective tissue within the mammary gland of a breastfeeding woman. It is a relatively common condition that causes pain and worry, and can lead to restriction in activity and increased risk of early weaning from breastfeeding. Staphylococcus aureus is the infectious agent most commonly implicated in lactation mastitis. It is well established that the anterior nares are the primary reservoir of S. aureus in humans and that approximately 20% of healthy individuals are "persistent carriers" of the organism. Carriage of Staphylococcus aureus has been identified as a significant risk factor for the development of infection including surgical wound infections. It has been suggested that maternal and infant nasal carriage of S. aureus may be associated with an increased risk of breast infection during lactation. We propose to prospectively study the relationship between the S. aureus carrier status of 500 healthy breastfeeding dyads and the rate of the subsequent development of lactational mastitis. Carrier status of mothers and infants will be determined through two nasal swabbings performed in the early post-partum period. The swabs will be analyzed with both traditional culture and through Polymerase chain reaction (PCR) amplification analysis. Mastitis rate will be determined via serial follow-up telephone interviews during the first two months post-partum.

Official TitleStaphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study
Principal SponsorState University of New York - Upstate Medical University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

557 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesPathologic Complete ResponseBacterial Infections and MycosesBacterial InfectionsBehaviorBreast DiseasesBreast FeedingFeeding BehaviorFemale Urogenital Diseases and Pregnancy ComplicationsInfectionsMastitisPathologic ProcessesPregnancy ComplicationsPuerperal DisordersSkin DiseasesStaphylococcal InfectionsPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsSkin and Connective Tissue DiseasesDisease ProgressionDisease Attributes

Criteria

7 inclusion criteria required to participate
Mother must plan to breastfeed exclusively for at least two months

Mother must be 18 years or older.

Mother must speak English and capable of giving informed consent

Must be the delivery of a term (37 weeks or more), singleton live infant.

Show More Criteria

1 exclusion criteria prevent from participating
Does not have the ability to drop off the second set of cultures.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

SUNY Upstate Medical University

Syracuse, United StatesOpen SUNY Upstate Medical University in Google Maps
CompletedOne Study Center