Clinical Trial: Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: State University of New York - Upstate Medical University
Current Primary Outcome: Our primary objective is to determine the association of nasal carriage of S. aureus in breastfeeding mothers and infants with the rate development of mastitis in the mothers. [ Time Frame: Culture results will be unblinded at the end of the study. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary objective will be to document the S. aureus carriage rate, including methicillin-resistant Staphylococcus aureus (MRSA), in early post-partum period and to assess the relationship between S. aureus carrier status of the mother and the infant. [ Time Frame: Culture results will be unblinded at the end of the study. ]
Original Secondary Outcome: Secondary objective will be to document the S. aureus carriage rate, including MRSA, in early post-partum period and to assess the relationship between S. aureus carrier status of the mother and the infant. [ Time Frame: Culture results will be unblinded at the end of the study. ]
Information By: State University of New York - Upstate Medical University
Dates:
Date Received: February 13, 2008
Date Started: August 2006
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015
