Staphylococcus Aureus Clinical Trial
Official title:
Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study
Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the
breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly
associated with lactation mastitis. Twenty percent of the general population are carriers of
Staphylococcus aureus, which means that they carry the infectious germ but do not become ill
from it. It has been suggested that mothers who are carriers of S. aureus in their nostril
may be at an increased risk of developing lactational mastitis, however; this has not been
clinical proven.
We are studying the relationship between S. aureus carrier status of breastfeeding mothers
and infants and the risk of developing lactational mastitis. Additionally, we are collecting
questionnaire data in an attempt to better define factors predisposing women to lactation
mastitis.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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